Phentermine Hydrochloride
- Product NDC
- 84053-676
- 11-digit product format
- 840530676
- Labeler code
- 84053
- Product ID
- 84053-676_3a9b6c60-a063-2709-e063-6394a90a6168
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phentermine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Martek Pharmacal Co.
- Application
- ANDA040526
- Marketing category
- ANDA
- Marketing start
- 2024-02-29
- Substance
- PHENTERMINE HYDROCHLORIDE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Phentermine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENTERMINE HYDROCHLORIDE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K2I505OTV |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84053-676-21 | Phentermine Hydrochloride | 21 in 1 BOTTLE | TABLET | 21 | | 3 |
| 84053-676-28 | Phentermine Hydrochloride | 28 in 1 BOTTLE | TABLET | 28 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 84053-676 | PHENTERMINE HYDROCHLORIDE TABLET [MARTEK PHARMACAL CO.] | 1 | Current NDC, 2 package rows | 20240302_12699287-9ca9-07b3-e063-6294a90af21a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84053-676-21 | 84053067621 | 21 TABLET in 1 BOTTLE (84053-676-21) | 21 tablet | 2024-02-29 | No | No | Current |
| 84053-676-28 | 84053067628 | 28 TABLET in 1 BOTTLE (84053-676-28) | 28 tablet | 2024-02-29 | No | No | Current |