Naratriptan
- Product NDC
- 0054-0279
- 11-digit product format
- 000540279
- Labeler code
- 0054
- Product ID
- 0054-0279_14eeba7d-700d-4ac1-a71e-d6a1fca8aaab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naratriptan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA090381
- Marketing category
- ANDA
- Marketing start
- 2010-07-07
- Substance
- NARATRIPTAN HYDROCHLORIDE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naratriptan
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NARATRIPTAN HYDROCHLORIDE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 10X8X4P12Z |
| Rxcui | 311918, 314135 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0279-03 | Naratriptan | 9 in 1 BOTTLE | TABLET | 9 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NARATRIPTAN HYDROCHLORIDE | ACTIVE INGREDIENT | 10X8X4P12Z | NARATRIPTAN TABLET [ROXANE LABORATORIES, INC.] | 3 | |
| NARATRIPTAN | ACTIVE MOIETY | QX3KXL1ZA2 | NARATRIPTAN TABLET [ROXANE LABORATORIES, INC.] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | NARATRIPTAN TABLET [ROXANE LABORATORIES, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NARATRIPTAN TABLET [ROXANE LABORATORIES, INC.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NARATRIPTAN TABLET [ROXANE LABORATORIES, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NARATRIPTAN TABLET [ROXANE LABORATORIES, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NARATRIPTAN TABLET [ROXANE LABORATORIES, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0279 | NARATRIPTAN TABLET [HIKMA PHARMACEUTICALS USA INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20230725_fd1944b3-8054-4faa-a82e-d818dfdd3875.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 |
|---|
| 0054-0279-03 | 00054027903 | 9 TABLET in 1 BOTTLE (0054-0279-03) | 9 tablet | 2010-10-07 | 0000-00-00 | No | No | Current |