Phentermine Hydrochloride
- Product NDC
- 76420-585
- 11-digit product format
- 764200585
- Labeler code
- 76420
- Product ID
- 76420-585_04472220-f8f9-1f1a-e063-6294a90a2bb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- phentermine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA205019
- Marketing category
- ANDA
- Marketing start
- 2017-01-24
- Substance
- PHENTERMINE HYDROCHLORIDE
- Active strength
- 15 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 | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K2I505OTV |
| Rxcui | 900038, 968766 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-585-10 | Phentermine Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 76420-585-30 | Phentermine Hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 76420-585-60 | Phentermine Hydrochloride | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
| 76420-585-90 | Phentermine Hydrochloride | 90 in 1 BOTTLE | CAPSULE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-585 | PHENTERMINE HYDROCHLORIDE CAPSULE [ASCLEMED USA, INC.] | 1 | Current NDC, 4 package rows | 20230902_22683183-a828-47a4-9e52-38175d7c6f21.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-585-10 | 76420058510 | 100 CAPSULE in 1 BOTTLE (76420-585-10) | 100 capsule | 2023-09-01 | No | No | Historical |
| 76420-585-30 | 76420058530 | 30 CAPSULE in 1 BOTTLE (76420-585-30) | 30 capsule | 2023-09-01 | No | No | Historical |
| 76420-585-60 | 76420058560 | 60 CAPSULE in 1 BOTTLE (76420-585-60) | 60 capsule | 2023-09-01 | No | No | Historical |
| 76420-585-90 | 76420058590 | 90 CAPSULE in 1 BOTTLE (76420-585-90) | 90 capsule | 2023-09-01 | No | No | Historical |