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NDC 53746-0116-01 Hydrocodone Bitartrate and Ibuprofen 2.5; 200 mg/1; mg/1 Details

Hydrocodone Bitartrate and Ibuprofen 2.5; 200 mg/1; mg/1

Hydrocodone Bitartrate and Ibuprofen is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals of New York LLC. The primary component is HYDROCODONE BITARTRATE; IBUPROFEN.

MedlinePlus Drug Summary

Hydrocodone is available in combination with other ingredients, and different combination products are prescribed for different uses. Some hydrocodone combination products are used to relieve moderate-to-severe pain. Other hydrocodone combination products are used to relieve cough. Hydrocodone is in a class of medications called opiate (narcotic) analgesics and in a class of medications called antitussives. Hydrocodone relieves pain by changing the way the brain and nervous system respond to pain. Hydrocodone relieves cough by decreasing activity in the part of the brain that causes coughing. You will take hydrocodone in combination with at least one other medication, but this monograph only provides information about hydrocodone. Be sure to read information about the other ingredients in the hydrocodone product you are taking. Ask your doctor or pharmacist if you have any questions.

Related Packages: 53746-0116-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocodone Combination Products

Product Information

NDC	53746-0116
Product ID	53746-116_6605b229-ede5-4ebf-b749-dde315916268
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Hydrocodone Bitartrate and Ibuprofen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hydrocodone Bitartrate and Ibuprofen
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	2.5; 200
Active Ingredient Units	mg/1; mg/1
Substance Name	HYDROCODONE BITARTRATE; IBUPROFEN
Labeler Name	Amneal Pharmaceuticals of New York LLC
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA Schedule	CII
Marketing Category	ANDA
Application Number	ANDA076642
Listing Certified Through	2024-12-31

Package

NDC 53746-0116-01 (53746011601)

Pricing Information	N/A
NDC Package Code	53746-116-01
Billing NDC	53746011601
Package	100 TABLET in 1 BOTTLE (53746-116-01)
Marketing Start Date	2010-02-18
NDC Exclude Flag	N