HYDROCODONE BITARTRATE
- Product NDC
- 61919-296
- 11-digit product format
- 619190296
- Labeler code
- 61919
- Product ID
- 61919-296_3fdeac85-5fd8-04fa-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA077723
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- 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],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61919-296-30 | HYDROCODONE BITARTRATE | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 2 |
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 | |
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-296 | HYDROCODONE BITARTRATE TABLET, COATED [DIRECT RX] | 2 | Legacy NDC, 1 package rows | 20161028_c386c4c5-f2f1-4078-a6fb-f120f56912e4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 61919-296-30 | 61919029630 | 30 in 1 BOTTLE | Historical |