Norco
- Product NDC
- 72189-399
- 11-digit product format
- 721890399
- Labeler code
- 72189
- Product ID
- 72189-399_2c4ce870-c59f-df00-e063-6394a90a9011
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone/APAP
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA040400
- Marketing category
- ANDA
- Marketing start
- 2022-11-23
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 10 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
- Norco
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| HYDROCODONE BITARTRATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-399-30 | Norco | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 72189-399-60 | Norco | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
| 72189-399-72 | Norco | 120 in 1 BOTTLE | TABLET | 120 | | 3 |
| 72189-399-90 | Norco | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-399 | NORCO (HYDROCODONE/APAP) TABLET [DIRECT_RX] | 3 | Current NDC, Legacy NDC, 4 package rows | 20250123_ee248dfd-7aa7-7dcc-e053-2995a90af19f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72189-399-30 | 72189039930 | 30 TABLET in 1 BOTTLE (72189-399-30) | 30 tablet | 2022-11-23 | 0000-00-00 | No | No | Current |
| 72189-399-60 | 72189039960 | 60 TABLET in 1 BOTTLE (72189-399-60) | 60 tablet | 2022-11-23 | 0000-00-00 | No | No | Current |
| 72189-399-72 | 72189039972 | 120 TABLET in 1 BOTTLE (72189-399-72) | 120 tablet | 2022-11-23 | | No | No | Historical |
| 72189-399-90 | 72189039990 | 90 TABLET in 1 BOTTLE (72189-399-90) | 90 tablet | 2022-11-23 | | No | No | Historical |