Phentermine Hydrochloride
- Product NDC
- 64850-810
- 11-digit product format
- 648500810
- Labeler code
- 64850
- Product ID
- 64850-810_f2b9f70f-b5e3-4e6e-8607-5c73afbe9677
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phentermine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Elite Laboratories, Inc.
- Application
- ANDA040190
- Marketing category
- ANDA
- Marketing start
- 2014-05-01
- 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 |
|---|
| 64850-810-01 | Phentermine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 64850-810-10 | Phentermine Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PHENTERMINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0K2I505OTV | PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] | 1 | |
| PHENTERMINE | ACTIVE MOIETY | C045TQL4WP | PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64850-810 | PHENTERMINE HYDROCHLORIDE TABLET [ELITE LABORATORIES, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241114_0b7ad9c0-9e1e-4a69-802b-28f44267e34d.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 |
|---|
| 64850-810-01 | 64850081001 | 100 TABLET in 1 BOTTLE (64850-810-01) | 100 tablet | 2014-05-01 | 0000-00-00 | No | No | Current |
| 64850-810-10 | 64850081010 | 1000 TABLET in 1 BOTTLE (64850-810-10) | 1000 tablet | 2014-05-01 | 0000-00-00 | No | No | Current |