BENZPHETAMINE HYDROCHLORIDE
- Product NDC
- 10702-040
- Requested package NDC
- 10702-040-01
- 11-digit product format
- 107020040
- Labeler code
- 10702
- Product ID
- 10702-040_15d75638-8ac7-e610-e063-6394a90af99c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzphetamine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- KVK-TECH, INC
- Application
- ANDA090968
- Marketing category
- ANDA
- Marketing start
- 2010-07-21
- Substance
- BENZPHETAMINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 10702-040 | 10702-040-01 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090968-001 | BENZPHETAMINE HYDROCHLORIDE | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090968-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090968-001 | BENZPHETAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | RS | 2010-07-20 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090968-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090968-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090968-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090968-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090968-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090968-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090968-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090968-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090968-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090968-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090968-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090968-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090968-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090968-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090968-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090968-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090968-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090968-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090968-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090968-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090968-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090968-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090968-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090968-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090968-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090968-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090968-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090968-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A090968-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A090968-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090968-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090968-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090968-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090968-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A090968-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A090968-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090968-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A090968-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A090968-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090968-001 | AA | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BENZPHETAMINE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZPHETAMINE HYDROCHLORIDE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 43DWT87QT7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 904368 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 14d4589d-7f1c-4b6e-9557-59dad39b0960 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| e1de3598-2dc1-55e2-fc07-ee2e74c73cfc | Product name | 3 | 20201013 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10702-040-01 | BENZPHETAMINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | 9 | |
| 10702-040-03 | BENZPHETAMINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | 9 | |
| 10702-040-10 | BENZPHETAMINE HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET | 1000 | 9 | |
| 10702-040-50 | BENZPHETAMINE HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET | 500 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10702-040-01 | EA - Each | 10702-040 | 5748339c-df30-4d23-a1c4-1694ac4d7eae | 1 | 2012-07-24 |
| 10702-040-03 | EA - Each | 10702-040 | caee5377-2bf9-40a0-b67d-9c3929eb70fe | 1 | 2012-07-24 |
| 10702-040-50 | EA - Each | 10702-040 | ae2db329-b758-4e62-88c8-efb211618622 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BENZPHETAMINE HYDROCHLORIDE | BENZPHETAMINE HYDROCHLORIDE | KVK-TECH, INC | 14d4589d-7f1c-4b6e-9557-59dad39b0960 | 2026-07-29 | Warnings, Adverse reactions | 090968 ANDA090968 10702-040-01 10702-040 10702004001 |
| BENZPHETAMINE HYDROCHLORIDE | BENZPHETAMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 2b7014af-0cc9-4199-90f2-ec07ac02f8cf | 2025-10-15 | Warnings, Adverse reactions | 090968 ANDA090968 |
| BENZPHETAMINE HYDROCHLORIDE | BENZPHETAMINE HYDROCHLORIDE | Bryant Ranch Prepack | 1c726aa7-3b78-45de-aca0-fd8a5fff9403 | 2024-05-29 | Warnings, Adverse reactions | 090968 ANDA090968 |
| benzphetamine hydrochloride | BENZPHETAMINE HYDROCHLORIDE | Calvin Scott & Co., Inc. | f5c3c2ed-54a2-1def-e053-2995a90ab4e3 | 2023-03-02 | Warnings, Adverse reactions | 090968 ANDA090968 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 904368 | benzphetamine HCl 50 MG Oral Tablet | PSN | 2b7014af-0cc9-4199-90f2-ec07ac02f8cf | 25 |
| 904368 | benzphetamine hydrochloride 50 MG Oral Tablet | SCD | 2b7014af-0cc9-4199-90f2-ec07ac02f8cf | 25 |
| 904368 | benzphetamine HCl 50 MG Oral Tablet | PSN | 1c726aa7-3b78-45de-aca0-fd8a5fff9403 | 10 |
| 904368 | benzphetamine hydrochloride 50 MG Oral Tablet | SCD | 1c726aa7-3b78-45de-aca0-fd8a5fff9403 | 10 |
| 904368 | benzphetamine HCl 50 MG Oral Tablet | PSN | 14d4589d-7f1c-4b6e-9557-59dad39b0960 | 9 |
| 904368 | benzphetamine hydrochloride 50 MG Oral Tablet | SCD | 14d4589d-7f1c-4b6e-9557-59dad39b0960 | 9 |
| 904368 | benzphetamine HCl 50 MG Oral Tablet | PSN | f5c3c2ed-54a2-1def-e053-2995a90ab4e3 | 2 |
| 904368 | benzphetamine hydrochloride 50 MG Oral Tablet | SCD | f5c3c2ed-54a2-1def-e053-2995a90ab4e3 | 2 |
| 904368 | benzphetamine HCl 50 MG Oral Tablet | PSN | 082a9bcf-f1ea-4c77-86e0-3699720514be | 1 |
| 904368 | benzphetamine hydrochloride 50 MG Oral Tablet | SCD | 082a9bcf-f1ea-4c77-86e0-3699720514be | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 10702-040-01 | 10702004001 | 100 TABLET in 1 BOTTLE (10702-040-01) | 100 tablet | 2010-07-21 | 0000-00-00 | No | No | Current |