Hydrocodone Bitartrate and Ibuprofen
- Product NDC
- 13107-004
- 11-digit product format
- 131070004
- Labeler code
- 13107
- Product ID
- 13107-004_ef408ee9-6806-423f-9998-53d81cc71b94
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurolife Pharma, LLC
- Application
- ANDA204575
- Marketing category
- ANDA
- Marketing start
- 2016-06-02
- Substance
- HYDROCODONE BITARTRATE; IBUPROFEN
- Active strength
- 7.5; 200 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocodone Bitartrate and Ibuprofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCODONE BITARTRATE | 7.5 mg/1 |
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NO70W886KK, WK2XYI10QM |
| Rxcui | 858798 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13107-004-01 | Hydrocodone Bitartrate and Ibuprofen | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 21 |
| 13107-004-05 | Hydrocodone Bitartrate and Ibuprofen | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 21 |
| 13107-004-11 | Hydrocodone Bitartrate and Ibuprofen | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 21 |
| 13107-004-99 | Hydrocodone Bitartrate and Ibuprofen | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13107-004 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AUROLIFE PHARMA, LLC] | 19 | Current NDC, Legacy NDC, 4 package rows | 20240802_470df63a-5c0f-42df-9023-a330a901153e.zip |
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 |
|---|
| 13107-004-01 | 13107000401 | 100 TABLET, FILM COATED in 1 BOTTLE (13107-004-01) | 2016-06-02 | 0000-00-00 | No | No | Current |
| 13107-004-05 | 13107000405 | 500 TABLET, FILM COATED in 1 BOTTLE (13107-004-05) | 2016-06-02 | 0000-00-00 | No | No | Current |
| 13107-004-11 | 13107000411 | 10 TABLET, FILM COATED in 1 BOTTLE (13107-004-11) | 2016-06-02 | 0000-00-00 | No | No | Current |
| 13107-004-99 | 13107000499 | 1000 TABLET, FILM COATED in 1 BOTTLE (13107-004-99) | 2016-06-02 | 0000-00-00 | No | No | Current |