Hydrocodone Bitartrate And Acetaminophen Solution
NDC Package 27808-049-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Hydrocodone Bitartrate And Acetaminophen solution is hydrocodone Bitartrate and Acetaminophen Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. This formulation utilizes a solution delivery system. Marketed by Cranbury Pharmaceuticals, Llc, this product is identified by NDC 27808-049 and is authorized under FDA application ANDA201295.

Identification & Billing

NDC Package Code
27808-049-01
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
27808-049
11-Digit Billing Format
27808004901
RxNorm Crosswalk
  • RxCUI: 856940 - HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG in 15 mL Oral Solution
  • RxCUI: 856940 - acetaminophen 21.7 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral Solution
  • RxCUI: 856940 - acetaminophen 108 MG / hydrocodone bitartrate 2.5 MG per 5 ML Oral Solution
  • RxCUI: 856940 - acetaminophen 217 MG / hydrocodone bitartrate 5 MG per 10 ML Oral Solution
  • RxCUI: 856940 - acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG per 15 ML Oral Solution

Clinical Specifications

Proprietary Name
Hydrocodone Bitartrate And Acetaminophen
Non-Proprietary Name
Hydrocodone Bitartrate And Acetaminophen
Substance Name
Acetaminophen; Hydrocodone Bitartrate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Hydrocodone Bitartrate and Acetaminophen Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Oral Solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):  •  have not been tolerated, or are not expected to be tolerated •  have not provided adequate analgesia, or are not expected to provide adequate analgesia
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Cranbury Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA201295
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-30-2021
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 27808-049-01 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Hydrocodone Bitartrate And Acetaminophen, a human prescription drug labeled by Cranbury Pharmaceuticals, Llc. This solution is formulated for oral use and contains acetaminophen; hydrocodone bitartrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Cranbury Pharmaceuticals, Llc on December 30, 2021. The current certification is valid through December 31, 2027.

How is this Cranbury Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 27808004901. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
27808-049-01
11-Digit CMS (5-4-2)
27808-0049-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.