NDC 0406-0378 Hydrocodone Bitartrate And Acetaminophen
Tablet Oral

Product Information

What is NDC 0406-0378?

The NDC code 0406-0378 is assigned by the FDA to the product Hydrocodone Bitartrate And Acetaminophen which is a human prescription drug product labeled by Specgx Llc. The product's dosage form is tablet and is administered via oral form. The product is distributed in 4 packages with assigned NDC codes 0406-0378-01 100 tablet in 1 bottle , 0406-0378-05 500 tablet in 1 bottle , 0406-0378-23 1 tablet in 1 blister pack , 0406-0378-62 10 blister pack in 1 carton / 10 tablet in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0406-0378
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.
Hydrocodone Bitartrate And Acetaminophen
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.
Hydrocodone Bitartrate And Acetaminophen
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
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Specgx Llc
Labeler Code0406
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.
DEA Schedule What is the Drug Enforcement Administration (DEA) CII Schedule?
The controlled substances in the CII schedule have a high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the United States. Schedule CII controlled substances include certain narcotic, stimulant, and depressant drugs.
Schedule II (CII) Substances
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.
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.
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.
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".
NDC Code Structure

What are the uses for Hydrocodone Bitartrate And Acetaminophen?

Product Characteristics

Color(s)WHITE (C48325)
ShapeOVAL (C48345)
Size(s)15 MM

Product Packages

NDC Code 0406-0378-01

Package Description: 100 TABLET in 1 BOTTLE

Price per Unit: $0.28399 per EA

NDC Code 0406-0378-05

Package Description: 500 TABLET in 1 BOTTLE

Price per Unit: $0.28399 per EA

NDC Code 0406-0378-23

Package Description: 1 TABLET in 1 BLISTER PACK

NDC Code 0406-0378-62

Package Description: 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK

Product Details

What are Hydrocodone Bitartrate And Acetaminophen Active Ingredients?

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.
  • ACETAMINOPHEN 300 mg/1 - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
  • HYDROCODONE BITARTRATE 10 mg/1 - Narcotic analgesic related to CODEINE, but more potent and more addicting by weight. It is used also as cough suppressant.

Hydrocodone Bitartrate And Acetaminophen Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 856980 - HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral Tablet
  • RxCUI: 856980 - acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral Tablet
  • RxCUI: 856980 - APAP 300 MG / hydrocodone bitartrate 10 MG Oral Tablet
  • RxCUI: 856987 - HYDROcodone bitartrate 5 MG / acetaminophen 300 MG Oral Tablet
  • RxCUI: 856987 - acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral Tablet

Hydrocodone Bitartrate And Acetaminophen Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education


Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Hydrocodone Combination Products

Hydrocodone Combination Products is pronounced as (hye droe koe' done)
Why is hydrocodone combination products medication prescribed?
Hydrocodone is available in combination with other ingredients, and different combination products are prescribed for different uses. Some hydrocodone combination product...
[Read More]

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Hydrocodone Bitartrate And Acetaminophen Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents

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