Phentermine Hydrochloride
- Product NDC
- 10544-602
- 11-digit product format
- 105440602
- Labeler code
- 10544
- Product ID
- 10544-602_adbf74c6-22f0-4951-aa7f-80c3677705ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phentermine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA040527
- Marketing category
- ANDA
- Marketing start
- 2009-12-30
- 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3d272a3f-17c0-421d-bc43-3cbdb719258d | Product name | 1 | 20250303 |
| 32c2b0bd-1f13-4890-99e0-dcd2ea16e1ab | Product name | 2 | 20230717 |
| ebeae3eb-385d-62da-8827-5ffa80b14e90 | Product name | 2 | 20170810 |
| 1d682039-1122-1cb7-f3f4-c0a028b98748 | Product name | 4 | 20170124 |
| 8ef9ca65-1a6c-7225-351d-36066d0f8e56 | Product name | 3 | 20161229 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10544-602-30 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-bee6-621f-e053-dbdaa90a74ad | PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV |
| 10544-602-45 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-bee6-621f-e053-dbdaa90a74ad | PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV |
| 10544-602-60 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-bee6-621f-e053-dbdaa90a74ad | PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10544-602-30 | Phentermine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 10544-602-45 | Phentermine Hydrochloride | 45 in 1 BOTTLE | TABLET | 45 | 3 | |
| 10544-602-60 | Phentermine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10544-602-30 | EA - Each | 10544-602 | 90cb8e91-d290-4ddf-b86c-dcfaa407e013 | 1 | 2015-10-02 |
| 10544-602-45 | EA - Each | 10544-602 | e71db32c-be18-4b4c-b96c-58a0685469bb | 1 | 2015-10-02 |
| 10544-602-60 | EA - Each | 10544-602 | 577b6a5c-f8ca-43c2-be7f-7b8d308a2dbd | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Phentermine Hydrochloride | ACTIVE INGREDIENT | 0K2I505OTV | PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| Phentermine | ACTIVE MOIETY | C045TQL4WP | PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 3 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | a3600c42-470a-4a36-9e9a-d74504de8c40 | 3 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | a3600c42-470a-4a36-9e9a-d74504de8c40 | 3 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | a3600c42-470a-4a36-9e9a-d74504de8c40 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 10544-602-30 | 10544060230 | 30 in 1 BOTTLE | Historical |
| 10544-602-45 | 10544060245 | 45 in 1 BOTTLE | Historical |
| 10544-602-60 | 10544060260 | 60 in 1 BOTTLE | Historical |