Phentermine Hydrochloride
- Product NDC
- 21695-513
- 11-digit product format
- 216950513
- Labeler code
- 21695
- Product ID
- 21695-513_29fce92f-babc-45f6-bc50-f3eb5ce7d9fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phentermine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA040527
- Marketing category
- ANDA
- Marketing start
- 2003-10-23
- 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 |
|---|---|---|---|---|---|
| 21695-513-00 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4bde-48b1-e053-8cdaa90a720a | PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV |
| 21695-513-07 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4bde-48b1-e053-8cdaa90a720a | PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV |
| 21695-513-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4bde-48b1-e053-8cdaa90a720a | PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-513-00 | Phentermine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 21695-513-07 | Phentermine Hydrochloride | 07 in 1 BOTTLE | TABLET | 07 | 1 | |
| 21695-513-30 | Phentermine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-513-00 | EA - Each | 21695-513 | 4531b28b-8c60-491b-b71f-4a1973aa92c8 | 1 | 2012-07-24 |
| 21695-513-07 | EA - Each | 21695-513 | 408042ff-4db4-41d0-b440-ab619f703855 | 1 | 2012-07-24 |
| 21695-513-30 | EA - Each | 21695-513 | 73615a8b-01e9-46f0-8027-2b1c60f1655f | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Phentermine Hydrochloride | ACTIVE INGREDIENT | 0K2I505OTV | PHENTERMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| Phentermine | ACTIVE MOIETY | C045TQL4WP | PHENTERMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | PHENTERMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | 7fb51344-baa4-4905-8ee7-a2db973786fc | 1 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | 7fb51344-baa4-4905-8ee7-a2db973786fc | 1 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | 7fb51344-baa4-4905-8ee7-a2db973786fc | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-513-00 | 21695051300 | 100 in 1 BOTTLE | Historical |
| 21695-513-07 | 21695051307 | 07 in 1 BOTTLE | Historical |
| 21695-513-30 | 21695051330 | 30 in 1 BOTTLE | Historical |