Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 13107-212
- 11-digit product format
- 131070212
- Labeler code
- 13107
- Product ID
- 13107-212_265ff2e7-c060-4a82-909b-26e71c262dd6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurolife Pharma, LLC
- Application
- ANDA207709
- Marketing category
- ANDA
- Marketing start
- 2015-05-06
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 300; 7.5 mg/1; mg/1
- Pharmacologic classes
- 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 Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 300 mg/1 |
| HYDROCODONE BITARTRATE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 856980, 856987, 856992 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13107-212-01 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 14 |
| 13107-212-05 | Hydrocodone Bitartrate and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | | 14 |
| 13107-212-30 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 14 |
| 13107-212-99 | Hydrocodone Bitartrate and Acetaminophen | 1000 in 1 BOTTLE | TABLET | 1000 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13107-212 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AUROLIFE PHARMA, LLC] | 12 | Current NDC, Legacy NDC, 4 package rows | 20240704_392a846e-7325-462d-b19b-8afda44c5cb0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13107-212-01 | 13107021201 | 100 TABLET in 1 BOTTLE (13107-212-01) | 100 tablet | 2015-05-06 | 0000-00-00 | No | No | Current |
| 13107-212-05 | 13107021205 | 500 TABLET in 1 BOTTLE (13107-212-05) | 500 tablet | 2015-05-06 | 0000-00-00 | No | No | Current |
| 13107-212-30 | 13107021230 | 30 TABLET in 1 BOTTLE (13107-212-30) | 30 tablet | 2015-05-06 | 0000-00-00 | No | No | Current |
| 13107-212-99 | 13107021299 | 1000 TABLET in 1 BOTTLE (13107-212-99) | 1000 tablet | 2015-05-06 | 0000-00-00 | No | No | Current |