Phentermine Hydrochloride
- Product NDC
- 0527-0597
- 11-digit product format
- 005270597
- Labeler code
- 0527
- Product ID
- 0527-0597_13517af4-9eee-422d-ae02-2a0f09101d74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phentermine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA087022
- Marketing category
- ANDA
- Marketing start
- 2007-12-01
- Marketing end
- 0000-00-00
- Substance
- PHENTERMINE HYDROCHLORIDE
- Active strength
- 30 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
- 2023-12-31
- 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 |
|---|---|---|---|---|---|
| 0527-0597-01 | 2024-01-30 | C162847 | 48780-1 | 1030e364-fd13-111a-e063-dadaa90a10e2 | 4af88a94-22c3-4da1-b8d9-a73ef68a51b6 |
| 0527-0597-10 | 2024-01-30 | C162847 | 48780-1 | 1030e364-fd13-111a-e063-dadaa90a10e2 | 4af88a94-22c3-4da1-b8d9-a73ef68a51b6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0527-0597-01 | EA - Each | 0527-0597 | 9ab2452a-1823-4c2c-94ea-a022df025f32 | 1 | 2012-07-24 |
| 0527-0597-10 | EA - Each | 0527-0597 | 5845393b-5952-4b45-ba57-1c7518b2ebde | 1 | 2012-07-24 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 900038 | phentermine HCl 30 MG Oral Capsule | PSN | b2d030fc-4169-40b0-8a91-112facb7d9a3 | 7 |
| 900038 | phentermine hydrochloride 30 MG Oral Capsule | SCD | b2d030fc-4169-40b0-8a91-112facb7d9a3 | 7 |
| 900038 | phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule | SY | b2d030fc-4169-40b0-8a91-112facb7d9a3 | 7 |
| 900038 | phentermine HCl 30 MG Oral Capsule | PSN | a84c17c6-cdd4-2f47-e053-2a95a90a959b | 3 |
| 900038 | phentermine hydrochloride 30 MG Oral Capsule | SCD | a84c17c6-cdd4-2f47-e053-2a95a90a959b | 3 |
| 900038 | phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule | SY | a84c17c6-cdd4-2f47-e053-2a95a90a959b | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0527-0597-01 | 00527059701 | 100 CAPSULE in 1 BOTTLE (0527-0597-01) | 100 capsule | 2007-12-01 | 0000-00-00 | No | No | Current |
| 0527-0597-10 | 00527059710 | 1000 CAPSULE in 1 BOTTLE (0527-0597-10) | 1000 capsule | 2007-12-01 | 0000-00-00 | No | No | Current |