Hydrocodone Bitartrate and Ibuprofen
- Product NDC
- 0603-3897
- 11-digit product format
- 006033897
- Labeler code
- 0603
- Product ID
- 0603-3897_5a16489b-5f9c-4961-8b6f-4fa15ebf7396
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocodone bitartrate and ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Par Pharmaceutical
- Application
- ANDA077723
- Marketing category
- ANDA
- Marketing start
- 2006-11-06
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; IBUPROFEN
- Active strength
- 8 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCODONE BITARTRATE | ACTIVE INGREDIENT | NO70W886KK | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| HYDROCODONE BITARTRATE | ACTIVE INGREDIENT | NO70W886KK | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| HYDROCODONE BITARTRATE | ACTIVE INGREDIENT | NO70W886KK | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0603-3897-21 | 00603389721 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-3897-21) | 2006-11-06 | 0000-00-00 | No | No | Current |
| 0603-3897-28 | 00603389728 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-3897-28) | 2006-11-06 | 0000-00-00 | No | No | Current |