Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 0406-0378
- 11-digit product format
- 004060378
- Labeler code
- 0406
- Product ID
- 0406-0378_84925071-325f-4e10-a767-378cbed0e59c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- ANDA206718
- Marketing category
- ANDA
- Marketing start
- 2017-03-31
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 300; 10 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocodone Bitartrate and Acetaminophen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 300 mg/1 |
| HYDROCODONE BITARTRATE | 10 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 |
|---|
| 0406-0378-01 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 24 |
| 0406-0378-05 | Hydrocodone Bitartrate and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | | 24 |
| 0406-0378-23 | Hydrocodone Bitartrate and Acetaminophen | 1 in 1 BLISTER PACK | TABLET | 1 | | 24 |
| 0406-0378-62 | Hydrocodone Bitartrate and Acetaminophen | 10 in 1 BLISTER PACK | TABLET | 10 | | 24 |
| 0406-0378-62 | Hydrocodone Bitartrate and Acetaminophen | 10 in 1 CARTON | TABLET | 10 | | 24 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0406-0378 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SPECGX LLC] | 22 | Current NDC, Legacy NDC, 5 package rows | 20240224_d621b526-4d9a-48a9-9a3e-d29d6aea2f31.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 |
|---|
| 0406-0378-01 | 00406037801 | 100 TABLET in 1 BOTTLE (0406-0378-01) | 100 tablet | 2017-03-31 | 0000-00-00 | No | No | Current |
| 0406-0378-05 | 00406037805 | 500 TABLET in 1 BOTTLE (0406-0378-05) | 500 tablet | 2017-03-31 | 0000-00-00 | No | No | Current |
| 0406-0378-23 | 00406037823 | 1 TABLET in 1 BLISTER PACK (0406-0378-23) | 1 tablet | 2017-03-31 | 0000-00-00 | No | No | Current |
| 0406-0378-62 | 00406037862 | 10 BLISTER PACK in 1 CARTON (0406-0378-62) > 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2017-03-31 | 0000-00-00 | No | No | Current |