NDC 0641-6116-10 Ampicillin And Sulbactam
Injection, Powder, For Solution Intravenous
Package Information
The table below has all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.
| NDC Package Code | 0641-6116-10 |
| Package Description | 10 VIAL in 1 CARTON / 1.5 g in 1 VIAL (0641-6116-01) |
| Product Code | 0641-6116 |
| Proprietary Name What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
Ampicillin And Sulbactam |
| Non-Proprietary Name What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
Ampicillin And Sulbactam |
| Substance Name What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted. |
Ampicillin Sodium; Sulbactam Sodium |
| Usage Information Product Usage Information The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs. |
Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*, Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis*, Bacteroides fragilis*, Enterobacter spp.*, and Acinetobacter calcoaceticus*.NOTE: For information on use in pediatric patients see PRECAUTIONS-Pediatric Use and CLINICAL STUDIES sections.Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli*, and Bacteroides spp.* (including B. fragilis*).*Efficacy for this organism in this organ system was studied in fewer than 10 infections.While Ampicillin and Sulbactam for Injection, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USP should not require the addition of another antibacterial.Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP.Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. |
| 11-Digit NDC Billing Format NDC Format for Billing For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration. |
00641611610 |
| Billing Unit | EA - Billing unit of "each" is used when the product is dispensed in discreet units. |
| Billable Units Calculator | 1 EA |
| NDC to RxNorm Crosswalk | |
| Product Type What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing. |
Human Prescription Drug |
| Labeler Name | Hikma Pharmaceuticals Usa Inc. |
| Dosage Form | Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use. |
| Administration Route(s) |
|
| Active Ingredient(s) | |
| Pharmacologic Class(es) | |
| Sample Package Sample Package? This field Indicates whether this package is a sample packaging or not. |
No |
| Marketing Category What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
ANDA - A product marketed under an approved Abbreviated New Drug Application. |
| FDA Application Number What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
ANDA065406 |
| Start Marketing Date What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product. |
12-22-2009 |
| Listing Expiration Date What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler. |
12-31-2023 |
| Exclude Flag What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". |
N |
| NDC Code Structure |
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The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the disclaimer below.
NDC HCPCS Crosswalk
This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.
NDC 0641-6116-10 HCPCS crosswalk information with package details and bill units information.
| NDC Billing Code | HCPCS Code | HCPCS Code Desc. | Dosage | Package Size | Package Quantity | Billable Units | Billable Units / Pkg |
|---|---|---|---|---|---|---|---|
| 00641611610 | J0295 | Ampicillin sulbactam 1.5 gm | 1.5 GM | 1 | 10 | 1 | 10 |
* Please review the disclaimer below.
Frequently Asked Questions
What is NDC 0641-6116-10?
The NDC Packaged Code 0641-6116-10 is assigned to a package of 10 vial in 1 carton / 1.5 g in 1 vial (0641-6116-01) of Ampicillin And Sulbactam, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is injection, powder, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.
Is NDC 0641-6116 included in the NDC Directory?
Yes, Ampicillin And Sulbactam with product code 0641-6116 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on December 22, 2009 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.
What is the NDC billing unit for package 0641-6116-10?
The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.
What is the 11-digit format for NDC 0641-6116-10?
The 11-digit format is 00641611610. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.
This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:
| 10-Digit Package Format | 10-Digit Original Package Code | 11-Digit Package Format | 11-Digit Conversion Package Code |
|---|---|---|---|
| 4-4-2 | 0641-6116-10 | 5-4-2 | 00641-6116-10 |