Phentermine Hydrochloride
- Product NDC
- 53489-676
- 11-digit product format
- 534890676
- Labeler code
- 53489
- Product ID
- 53489-676_39e24c57-7266-2bf6-e063-6294a90afdd1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phentermine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA040526
- Marketing category
- ANDA
- Marketing start
- 2013-08-12
- Substance
- PHENTERMINE HYDROCHLORIDE
- Active strength
- 37.5 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 | 37.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K2I505OTV |
| Rxcui | 803353 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53489-676-01 | Phentermine Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 10 |
| 53489-676-03 | Phentermine Hydrochloride | 250 in 1 BOTTLE, PLASTIC | TABLET | 250 | | 10 |
| 53489-676-05 | Phentermine Hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 10 |
| 53489-676-06 | Phentermine Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 10 |
| 53489-676-07 | Phentermine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 10 |
| 53489-676-10 | Phentermine Hydrochloride | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53489-676 | PHENTERMINE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 9 | Current NDC, Legacy NDC, 6 package rows | 20200228_02b8f684-b1ca-4ab7-9567-bcacc6a92779.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 |
|---|
| 53489-676-01 | 53489067601 | 100 TABLET in 1 BOTTLE, PLASTIC (53489-676-01) | 100 tablet | 2013-08-12 | 0000-00-00 | No | No | Current |
| 53489-676-03 | 53489067603 | 250 TABLET in 1 BOTTLE, PLASTIC (53489-676-03) | 250 tablet | 2013-08-12 | 0000-00-00 | No | No | Current |
| 53489-676-05 | 53489067605 | 500 TABLET in 1 BOTTLE, PLASTIC (53489-676-05) | 500 tablet | 2013-08-12 | 0000-00-00 | No | No | Current |
| 53489-676-06 | 53489067606 | 60 TABLET in 1 BOTTLE, PLASTIC (53489-676-06) | 60 tablet | 2013-08-12 | 0000-00-00 | No | No | Current |
| 53489-676-07 | 53489067607 | 30 TABLET in 1 BOTTLE, PLASTIC (53489-676-07) | 30 tablet | 2013-08-12 | 0000-00-00 | No | No | Current |
| 53489-676-10 | 53489067610 | 1000 TABLET in 1 BOTTLE, PLASTIC (53489-676-10) | 1000 tablet | 2013-08-12 | 0000-00-00 | No | No | Current |