Phentermine Hydrochloride
- Product NDC
- 10702-026
- 11-digit product format
- 107020026
- Labeler code
- 10702
- Product ID
- 10702-026_1662a72d-c285-b644-e063-6294a90a7333
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phentermine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- KVK-Tech, Inc.
- Application
- ANDA040886
- Marketing category
- ANDA
- Marketing start
- 2012-08-07
- Substance
- PHENTERMINE HYDROCHLORIDE
- Active strength
- 15 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 |
|---|---|---|---|---|---|---|---|
| A040886-001 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2008-03-31 | |
| A040886-002 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2008-03-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040886-001 | AA |
| A040886-002 | 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 | A040886-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2008-03-31 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A040886-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / 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 | A040886-001 | AA | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A040886-002 | 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 | Calvin Scott & Co., Inc. | 2f3b738f-d66b-40c1-8e69-bcd50bce3e47 | 2026-05-21 | Warnings, Adverse reactions | 040886 ANDA040886 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 4000c00f-aa6c-4ea5-af0e-149dde3c74db | 2025-10-20 | Warnings, Adverse reactions | 040886 ANDA040886 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | f115ad6d-cf62-40e7-89d1-6183a9b5071f | 2025-10-17 | Warnings, Adverse reactions | 040886 ANDA040886 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 2abc445c-daa8-7326-e054-00144ff88e88 | 2025-10-15 | Warnings, Adverse reactions | 040886 ANDA040886 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | A-S Medication Solutions | 5234cabd-6b3e-404d-a0cd-256ee5fcc8f1 | 2025-10-08 | Warnings, Adverse reactions | 040886 ANDA040886 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Martek Pharmacal Co. | 1fe86035-19ef-4944-ad81-c0167a8e7fec | 2025-07-23 | Warnings, Adverse reactions | 040886 ANDA040886 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Martek Pharmacal Co. | 1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd | 2025-07-21 | Warnings, Adverse reactions | 040886 ANDA040886 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 0b4d847a-fcda-df31-e063-6294a90a0c5e | 2025-02-03 | Warnings, Adverse reactions | 040886 ANDA040886 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 7f1c3a5d-dd9b-4441-a483-aa5777f8e40c | 2024-05-29 | Warnings, Adverse reactions | 040886 ANDA040886 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | KVK-Tech, Inc. | b963f7bb-fa65-4e28-81c9-282fbe70a6a6 | 2024-04-18 | Warnings, Adverse reactions | 040886 ANDA040886 10702-026 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Proficient Rx LP | 3a3259ec-ded3-427f-843d-928d130de3da | 2020-03-01 | Adverse reactions | 040886 ANDA040886 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Phentermine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENTERMINE HYDROCHLORIDE | 15 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0K2I505OTV | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b963f7bb-fa65-4e28-81c9-282fbe70a6a6 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10702-026-01 | Phentermine Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | 7 | |
| 10702-026-03 | Phentermine Hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | 7 | |
| 10702-026-10 | Phentermine Hydrochloride | 1000 in 1 BOTTLE | CAPSULE | 1000 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10702-026-01 | EA - Each | 10702-026 | 0a332356-3cfb-4215-8616-636ff909105f | 1 | 2013-02-13 |
| 10702-026-10 | EA - Each | 10702-026 | 689c93e8-cdaf-4397-b6dd-24f5fb49c1a8 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 968766 | phentermine HCl 15 MG Oral Capsule | PSN | 5234cabd-6b3e-404d-a0cd-256ee5fcc8f1 | 32 |
| 900038 | phentermine HCl 30 MG Oral Capsule | PSN | 5234cabd-6b3e-404d-a0cd-256ee5fcc8f1 | 32 |
| 968766 | phentermine hydrochloride 15 MG Oral Capsule | SCD | 5234cabd-6b3e-404d-a0cd-256ee5fcc8f1 | 32 |
| 900038 | phentermine hydrochloride 30 MG Oral Capsule | SCD | 5234cabd-6b3e-404d-a0cd-256ee5fcc8f1 | 32 |
| 968766 | phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule | SY | 5234cabd-6b3e-404d-a0cd-256ee5fcc8f1 | 32 |
| 900038 | phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule | SY | 5234cabd-6b3e-404d-a0cd-256ee5fcc8f1 | 32 |
| 968766 | phentermine HCl 15 MG Oral Capsule | PSN | f115ad6d-cf62-40e7-89d1-6183a9b5071f | 15 |
| 968766 | phentermine HCl 15 MG Oral Capsule | PSN | 4000c00f-aa6c-4ea5-af0e-149dde3c74db | 15 |
| 968766 | phentermine hydrochloride 15 MG Oral Capsule | SCD | f115ad6d-cf62-40e7-89d1-6183a9b5071f | 15 |
| 968766 | phentermine hydrochloride 15 MG Oral Capsule | SCD | 4000c00f-aa6c-4ea5-af0e-149dde3c74db | 15 |
| 968766 | phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule | SY | f115ad6d-cf62-40e7-89d1-6183a9b5071f | 15 |
| 968766 | phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule | SY | 4000c00f-aa6c-4ea5-af0e-149dde3c74db | 15 |
| 968766 | phentermine HCl 15 MG Oral Capsule | PSN | 8dfa13d3-c968-4cc8-bff9-ad06d55a5da5 | 7 |
| 968766 | phentermine HCl 15 MG Oral Capsule | PSN | b963f7bb-fa65-4e28-81c9-282fbe70a6a6 | 7 |
| 900038 | phentermine HCl 30 MG Oral Capsule | PSN | b963f7bb-fa65-4e28-81c9-282fbe70a6a6 | 7 |
| 968766 | phentermine hydrochloride 15 MG Oral Capsule | SCD | b963f7bb-fa65-4e28-81c9-282fbe70a6a6 | 7 |
| 968766 | phentermine hydrochloride 15 MG Oral Capsule | SCD | 8dfa13d3-c968-4cc8-bff9-ad06d55a5da5 | 7 |
| 900038 | phentermine hydrochloride 30 MG Oral Capsule | SCD | b963f7bb-fa65-4e28-81c9-282fbe70a6a6 | 7 |
| 968766 | phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule | SY | b963f7bb-fa65-4e28-81c9-282fbe70a6a6 | 7 |
| 968766 | phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule | SY | 8dfa13d3-c968-4cc8-bff9-ad06d55a5da5 | 7 |
| 900038 | phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule | SY | b963f7bb-fa65-4e28-81c9-282fbe70a6a6 | 7 |
| 968766 | phentermine HCl 15 MG Oral Capsule | PSN | 3a3259ec-ded3-427f-843d-928d130de3da | 4 |
| 968766 | phentermine HCl 15 MG Oral Capsule | PSN | 375bfe83-c893-3ea7-e054-00144ff88e88 | 4 |
| 968766 | phentermine HCl 15 MG Oral Capsule | PSN | 5866bdc2-1bf1-48d4-bbd2-b50d8276344c | 4 |
| 900038 | phentermine HCl 30 MG Oral Capsule | PSN | 5866bdc2-1bf1-48d4-bbd2-b50d8276344c | 4 |
| 968766 | phentermine hydrochloride 15 MG Oral Capsule | SCD | 3a3259ec-ded3-427f-843d-928d130de3da | 4 |
| 968766 | phentermine hydrochloride 15 MG Oral Capsule | SCD | 375bfe83-c893-3ea7-e054-00144ff88e88 | 4 |
| 968766 | phentermine hydrochloride 15 MG Oral Capsule | SCD | 5866bdc2-1bf1-48d4-bbd2-b50d8276344c | 4 |
| 900038 | phentermine hydrochloride 30 MG Oral Capsule | SCD | 5866bdc2-1bf1-48d4-bbd2-b50d8276344c | 4 |
| 968766 | phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule | SY | 5866bdc2-1bf1-48d4-bbd2-b50d8276344c | 4 |
| 968766 | phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule | SY | 375bfe83-c893-3ea7-e054-00144ff88e88 | 4 |
| 968766 | phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule | SY | 3a3259ec-ded3-427f-843d-928d130de3da | 4 |
| 900038 | phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule | SY | 5866bdc2-1bf1-48d4-bbd2-b50d8276344c | 4 |
| 968766 | phentermine HCl 15 MG Oral Capsule | PSN | 36d2ea29-4599-6ac9-e054-00144ff88e88 | 2 |
| 968766 | phentermine HCl 15 MG Oral Capsule | PSN | 1fe86035-19ef-4944-ad81-c0167a8e7fec | 2 |
| 968766 | phentermine hydrochloride 15 MG Oral Capsule | SCD | 1fe86035-19ef-4944-ad81-c0167a8e7fec | 2 |
| 968766 | phentermine hydrochloride 15 MG Oral Capsule | SCD | 36d2ea29-4599-6ac9-e054-00144ff88e88 | 2 |
| 968766 | phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule | SY | 1fe86035-19ef-4944-ad81-c0167a8e7fec | 2 |
| 968766 | phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule | SY | 36d2ea29-4599-6ac9-e054-00144ff88e88 | 2 |
| 968766 | phentermine HCl 15 MG Oral Capsule | PSN | 8aa97532-fd13-44b0-9b77-6165a35b6809 | 1 |
| 968766 | phentermine HCl 15 MG Oral Capsule | PSN | 42a2586d-b025-4a42-83a3-747a880ed858 | 1 |
| 968766 | phentermine HCl 15 MG Oral Capsule | PSN | 792831e9-ce9d-4d2d-ad98-80869c4c163f | 1 |
| 900038 | phentermine HCl 30 MG Oral Capsule | PSN | 792831e9-ce9d-4d2d-ad98-80869c4c163f | 1 |
| 968766 | phentermine hydrochloride 15 MG Oral Capsule | SCD | 42a2586d-b025-4a42-83a3-747a880ed858 | 1 |
| 968766 | phentermine hydrochloride 15 MG Oral Capsule | SCD | 8aa97532-fd13-44b0-9b77-6165a35b6809 | 1 |
| 968766 | phentermine hydrochloride 15 MG Oral Capsule | SCD | 792831e9-ce9d-4d2d-ad98-80869c4c163f | 1 |
| 900038 | phentermine hydrochloride 30 MG Oral Capsule | SCD | 792831e9-ce9d-4d2d-ad98-80869c4c163f | 1 |
| 968766 | phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule | SY | 8aa97532-fd13-44b0-9b77-6165a35b6809 | 1 |
| 968766 | phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule | SY | 42a2586d-b025-4a42-83a3-747a880ed858 | 1 |
| 968766 | phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule | SY | 792831e9-ce9d-4d2d-ad98-80869c4c163f | 1 |
| 900038 | phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule | SY | 792831e9-ce9d-4d2d-ad98-80869c4c163f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 10702-026-01 | 10702002601 | 100 CAPSULE in 1 BOTTLE (10702-026-01) | 100 capsule | 2012-08-07 | 0000-00-00 | No | No | Current |
| 10702-026-03 | 10702002603 | 30 CAPSULE in 1 BOTTLE (10702-026-03) | 30 capsule | 2012-08-07 | 0000-00-00 | No | No | Current |
| 10702-026-10 | 10702002610 | 1000 CAPSULE in 1 BOTTLE (10702-026-10) | 1000 capsule | 2012-08-07 | 0000-00-00 | No | No | Current |