Diethylpropion Hydrochloride
- Product NDC
- 12634-530
- Requested package NDC
- 12634-530-66
- 11-digit product format
- 126340530
- Labeler code
- 12634
- Product ID
- 12634-530_46cc3fe9-641c-5efd-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diethylpropion hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotheca Inc.
- Application
- NDA011722
- Marketing category
- NDA
- Marketing start
- 1959-08-06
- Marketing end
- 0000-00-00
- Substance
- DIETHYLPROPION HYDROCHLORIDE
- Active strength
- 25 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 12634-530 | 12634-530-66 | I | Inactivated by FDA | 2026-08-11 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | fb8cb913e6d1… | eb8c232b6be0… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N011722-002 | TENUATE | DIETHYLPROPION HYDROCHLORIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |
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 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | AA | RLD, RS, Approved before 1982 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N011722-002 | TENUATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N011722-002 | TENUATE | 25MG | TABLET / ORAL | RLD, Approved before 1982 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | N011722-002 | AA | 1 | ea99ee380514… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 0029c986-f448-4e26-865d-441bd9700d12 | Product name | 1 | 20201013 |
| a29cb53e-8fe0-4754-9013-e084b50c1c66 | Product name | 1 | 20170614 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 12634-530-00 | Diethylpropion Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | 3 | |
| 12634-530-01 | Diethylpropion Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 12634-530-09 | Diethylpropion Hydrochloride | 35 in 1 BOTTLE | TABLET | 35 | 3 | |
| 12634-530-12 | Diethylpropion Hydrochloride | 120 in 1 BOTTLE | TABLET | 120 | 3 | |
| 12634-530-18 | Diethylpropion Hydrochloride | 180 in 1 BOTTLE | TABLET | 180 | 3 | |
| 12634-530-40 | Diethylpropion Hydrochloride | 40 in 1 BOTTLE | TABLET | 40 | 3 | |
| 12634-530-42 | Diethylpropion Hydrochloride | 42 in 1 BOTTLE | TABLET | 42 | 3 | |
| 12634-530-45 | Diethylpropion Hydrochloride | 45 in 1 BOTTLE | TABLET | 45 | 3 | |
| 12634-530-50 | Diethylpropion Hydrochloride | 50 in 1 BOTTLE | TABLET | 50 | 3 | |
| 12634-530-52 | Diethylpropion Hydrochloride | 12 in 1 BLISTER PACK | TABLET | 12 | 3 | |
| 12634-530-54 | Diethylpropion Hydrochloride | 14 in 1 BLISTER PACK | TABLET | 14 | 3 | |
| 12634-530-57 | Diethylpropion Hydrochloride | 20 in 1 BLISTER PACK | TABLET | 20 | 3 | |
| 12634-530-59 | Diethylpropion Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | 3 | |
| 12634-530-60 | Diethylpropion Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 3 | |
| 12634-530-61 | Diethylpropion Hydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | 3 | |
| 12634-530-63 | Diethylpropion Hydrochloride | 3 in 1 BLISTER PACK | TABLET | 3 | 3 | |
| 12634-530-66 | Diethylpropion Hydrochloride | 6 in 1 BLISTER PACK | TABLET | 6 | 3 | |
| 12634-530-67 | Diethylpropion Hydrochloride | 7 in 1 BLISTER PACK | TABLET | 7 | 3 | |
| 12634-530-69 | Diethylpropion Hydrochloride | 9 in 1 BLISTER PACK | TABLET | 9 | 3 | |
| 12634-530-71 | Diethylpropion Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 12634-530-74 | Diethylpropion Hydrochloride | 24 in 1 BOTTLE | TABLET | 24 | 3 | |
| 12634-530-78 | Diethylpropion Hydrochloride | 28 in 1 BOTTLE | TABLET | 28 | 3 | |
| 12634-530-79 | Diethylpropion Hydrochloride | 25 in 1 BOTTLE | TABLET | 25 | 3 | |
| 12634-530-80 | Diethylpropion Hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | 3 | |
| 12634-530-81 | Diethylpropion Hydrochloride | 21 in 1 BOTTLE | TABLET | 21 | 3 | |
| 12634-530-82 | Diethylpropion Hydrochloride | 12 in 1 BOTTLE | TABLET | 12 | 3 | |
| 12634-530-84 | Diethylpropion Hydrochloride | 14 in 1 BOTTLE | TABLET | 14 | 3 | |
| 12634-530-85 | Diethylpropion Hydrochloride | 15 in 1 BOTTLE | TABLET | 15 | 3 | |
| 12634-530-90 | Diethylpropion Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | 3 | |
| 12634-530-91 | Diethylpropion Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | 3 | |
| 12634-530-92 | Diethylpropion Hydrochloride | 2 in 1 BOTTLE | TABLET | 2 | 3 | |
| 12634-530-93 | Diethylpropion Hydrochloride | 3 in 1 BOTTLE | TABLET | 3 | 3 | |
| 12634-530-94 | Diethylpropion Hydrochloride | 4 in 1 BOTTLE | TABLET | 4 | 3 | |
| 12634-530-95 | Diethylpropion Hydrochloride | 5 in 1 BOTTLE | TABLET | 5 | 3 | |
| 12634-530-96 | Diethylpropion Hydrochloride | 6 in 1 BOTTLE | TABLET | 6 | 3 | |
| 12634-530-97 | Diethylpropion Hydrochloride | 7 in 1 BOTTLE | TABLET | 7 | 3 | |
| 12634-530-98 | Diethylpropion Hydrochloride | 8 in 1 BOTTLE | TABLET | 8 | 3 | |
| 12634-530-99 | Diethylpropion Hydrochloride | 9 in 1 BOTTLE | TABLET | 9 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 978654 | diethylpropion HCl 25 MG Oral Tablet | PSN | 0971fa2e-d660-48b0-9fbb-96a2db167b92 | 3 |
| 978654 | diethylpropion hydrochloride 25 MG Oral Tablet | SCD | 0971fa2e-d660-48b0-9fbb-96a2db167b92 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 12634-530-66 | 12634053066 | 6 TABLET in 1 BLISTER PACK (12634-530-66) | 6 tablet | 2017-01-23 | 0000-00-00 | No | No | Current |