Phentermine Hydrochloride
- Product NDC
- 10702-025
- 11-digit product format
- 107020025
- Labeler code
- 10702
- Product ID
- 10702-025_1159ef2a-b2ca-518e-e063-6394a90a7543
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phentermine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- KVK-TECH, Inc.
- Application
- ANDA040876
- Marketing category
- ANDA
- Marketing start
- 2012-08-15
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040876-001 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040876-001 | AA |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A040876-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2008-03-31 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A040876-001 | AA | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Northwind Health Company, LLC | 5528d9f7-45ad-d323-e063-6394a90a3e09 | 2026-06-25 | Warnings, Adverse reactions | 040876 ANDA040876 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | A-S Medication Solutions | 86ec6b9d-2934-4bad-8a80-0b60e2f912f3 | 2026-01-24 | Warnings, Adverse reactions | 040876 ANDA040876 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 68fcc228-5f06-4ece-94f3-59b5b33c3325 | 2025-10-20 | Warnings, Adverse reactions | 040876 ANDA040876 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Martek Pharmacal Co. | c4e9ec2e-4660-4442-93d7-c05a16e137b5 | 2025-07-23 | Warnings, Adverse reactions | 040876 ANDA040876 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 315b8a94-b7cc-1b47-e063-6294a90a2d39 | 2025-03-27 | Warnings, Adverse reactions | 040876 ANDA040876 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Calvin Scott & Co., Inc. | 2d7ddbc2-2afc-473e-a73b-b44ab9fcfaab | 2025-02-26 | Warnings, Adverse reactions | 040876 ANDA040876 |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | DirectRx | d27d8379-aa3c-4688-e053-2995a90a44f6 | 2025-01-20 | Warnings, Adverse reactions | 040876 ANDA040876 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 2bd5487d-10da-4ae0-9105-273e1a5efdcb | 2024-08-20 | Warnings, Adverse reactions | 040876 ANDA040876 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | KVK-TECH, Inc. | 3b44d104-a7d0-4366-9d42-63f784f3cb22 | 2024-02-14 | Warnings, Adverse reactions | 040876 ANDA040876 10702-025 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Phentermine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENTERMINE HYDROCHLORIDE | 37.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0K2I505OTV | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3b44d104-a7d0-4366-9d42-63f784f3cb22 | Available on FDA.report |
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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10702-025-01 | Phentermine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 10 | |
| 10702-025-03 | Phentermine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 10 | |
| 10702-025-10 | Phentermine Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10702-025-01 | EA - Each | 10702-025 | 4f4b30e4-313a-447e-81ff-b7538a300ab0 | 1 | 2013-02-13 |
| 10702-025-03 | EA - Each | 10702-025 | c5a1d001-cc2d-4ea6-83e3-58e7c048661c | 1 | 2013-02-13 |
| 10702-025-10 | EA - Each | 10702-025 | 123b8669-c33f-4149-aa8f-1ad141bb746f | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | 2bd5487d-10da-4ae0-9105-273e1a5efdcb | 1009 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | 2bd5487d-10da-4ae0-9105-273e1a5efdcb | 1009 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | 2bd5487d-10da-4ae0-9105-273e1a5efdcb | 1009 |
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | 86ec6b9d-2934-4bad-8a80-0b60e2f912f3 | 21 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | 86ec6b9d-2934-4bad-8a80-0b60e2f912f3 | 21 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | 86ec6b9d-2934-4bad-8a80-0b60e2f912f3 | 21 |
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | 68fcc228-5f06-4ece-94f3-59b5b33c3325 | 20 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | 68fcc228-5f06-4ece-94f3-59b5b33c3325 | 20 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | 68fcc228-5f06-4ece-94f3-59b5b33c3325 | 20 |
| 803348 | phentermine HCl 37.5 MG Oral Capsule | PSN | 3b44d104-a7d0-4366-9d42-63f784f3cb22 | 10 |
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | 3b44d104-a7d0-4366-9d42-63f784f3cb22 | 10 |
| 803348 | phentermine hydrochloride 37.5 MG Oral Capsule | SCD | 3b44d104-a7d0-4366-9d42-63f784f3cb22 | 10 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | 3b44d104-a7d0-4366-9d42-63f784f3cb22 | 10 |
| 803348 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Capsule | SY | 3b44d104-a7d0-4366-9d42-63f784f3cb22 | 10 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | 3b44d104-a7d0-4366-9d42-63f784f3cb22 | 10 |
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | c4e9ec2e-4660-4442-93d7-c05a16e137b5 | 5 |
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | 92e46d41-e566-474e-bebc-be282113ed3b | 5 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | 92e46d41-e566-474e-bebc-be282113ed3b | 5 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | c4e9ec2e-4660-4442-93d7-c05a16e137b5 | 5 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | c4e9ec2e-4660-4442-93d7-c05a16e137b5 | 5 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | 92e46d41-e566-474e-bebc-be282113ed3b | 5 |
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | d27d8379-aa3c-4688-e053-2995a90a44f6 | 3 |
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | 2d7ddbc2-2afc-473e-a73b-b44ab9fcfaab | 3 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | 2d7ddbc2-2afc-473e-a73b-b44ab9fcfaab | 3 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | d27d8379-aa3c-4688-e053-2995a90a44f6 | 3 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | d27d8379-aa3c-4688-e053-2995a90a44f6 | 3 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | 2d7ddbc2-2afc-473e-a73b-b44ab9fcfaab | 3 |
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | fd9d346d-edae-477f-b2d4-278b9403bc89 | 2 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | fd9d346d-edae-477f-b2d4-278b9403bc89 | 2 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | fd9d346d-edae-477f-b2d4-278b9403bc89 | 2 |
| 803348 | phentermine HCl 37.5 MG Oral Capsule | PSN | 85e25827-c2bc-46d7-bc30-edf60f8258a3 | 1 |
| 803348 | phentermine HCl 37.5 MG Oral Capsule | PSN | e6ea6906-c4c9-4d59-9816-d2ffb1f042de | 1 |
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | 85e25827-c2bc-46d7-bc30-edf60f8258a3 | 1 |
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | ea960b39-a4b9-4f88-ad06-f96676d7044f | 1 |
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | e6ea6906-c4c9-4d59-9816-d2ffb1f042de | 1 |
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | 315b8a94-b7cc-1b47-e063-6294a90a2d39 | 1 |
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | 462eefa0-6224-42c2-af3f-c598de0d8010 | 1 |
| 803348 | phentermine hydrochloride 37.5 MG Oral Capsule | SCD | e6ea6906-c4c9-4d59-9816-d2ffb1f042de | 1 |
| 803348 | phentermine hydrochloride 37.5 MG Oral Capsule | SCD | 85e25827-c2bc-46d7-bc30-edf60f8258a3 | 1 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | 462eefa0-6224-42c2-af3f-c598de0d8010 | 1 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | 315b8a94-b7cc-1b47-e063-6294a90a2d39 | 1 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | e6ea6906-c4c9-4d59-9816-d2ffb1f042de | 1 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | 85e25827-c2bc-46d7-bc30-edf60f8258a3 | 1 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | ea960b39-a4b9-4f88-ad06-f96676d7044f | 1 |
| 803348 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Capsule | SY | e6ea6906-c4c9-4d59-9816-d2ffb1f042de | 1 |
| 803348 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Capsule | SY | 85e25827-c2bc-46d7-bc30-edf60f8258a3 | 1 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | 462eefa0-6224-42c2-af3f-c598de0d8010 | 1 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | e6ea6906-c4c9-4d59-9816-d2ffb1f042de | 1 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | ea960b39-a4b9-4f88-ad06-f96676d7044f | 1 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | 85e25827-c2bc-46d7-bc30-edf60f8258a3 | 1 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | 315b8a94-b7cc-1b47-e063-6294a90a2d39 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 10702-025-01 | 10702002501 | 100 TABLET in 1 BOTTLE (10702-025-01) | 100 tablet | 2012-08-15 | 0000-00-00 | No | No | Current |
| 10702-025-03 | 10702002503 | 30 TABLET in 1 BOTTLE (10702-025-03) | 30 tablet | 2012-08-15 | 0000-00-00 | No | No | Current |
| 10702-025-10 | 10702002510 | 1000 TABLET in 1 BOTTLE (10702-025-10) | 1000 tablet | 2012-08-15 | 0000-00-00 | No | No | Current |