Details for New Drug Application (NDA): 040148
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The generic ingredient in NORCO is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 040148
Tradename: | NORCO |
Applicant: | Apil |
Ingredient: | acetaminophen; hydrocodone bitartrate |
Patents: | 0 |
Pharmacology for NDA: 040148
Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 040148
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040148 | ANDA | Major Pharmaceuticals | 0904-6420 | 0904-6420-61 | 100 BLISTER PACK in 1 CARTON (0904-6420-61) / 1 TABLET in 1 BLISTER PACK |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | acetaminophen; hydrocodone bitartrate | TABLET;ORAL | 040148 | ANDA | Major Pharmaceuticals | 0904-6421 | 0904-6421-61 | 100 BLISTER PACK in 1 CARTON (0904-6421-61) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;10MG | ||||
Approval Date: | Feb 14, 1997 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG;10MG | ||||
Approval Date: | Feb 14, 1997 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;7.5MG | ||||
Approval Date: | Sep 12, 2000 | TE: | RLD: | No |
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