Phentermine Hydrochloride
- Product NDC
- 10544-116
- 11-digit product format
- 105440116
- Labeler code
- 10544
- Product ID
- 10544-116_cd3179bd-28a3-4fb0-ba34-d8c8ba3b7267
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phentermine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA040876
- Marketing category
- ANDA
- Marketing start
- 2009-12-21
- Marketing end
- 0000-00-00
- Substance
- PHENTERMINE HYDROCHLORIDE
- Active strength
- 38 mg/1
- Pharmacologic classes
- Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-116-21 | Phentermine Hydrochloride | 21 in 1 BOTTLE | TABLET | 21 | | 1 |
| 10544-116-30 | Phentermine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PHENTERMINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0K2I505OTV | PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| PHENTERMINE | ACTIVE MOIETY | C045TQL4WP | PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-116 | PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 2 package rows | 20130525_85e25827-c2bc-46d7-bc30-edf60f8258a3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-116-21 | 10544011621 | 21 in 1 BOTTLE | Historical |
| 10544-116-30 | 10544011630 | 30 in 1 BOTTLE | Historical |