Diethylpropion Hydrochloride

Product NDC
12634-530
Requested package NDC
12634-530-09
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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage12634-53012634-530-09IInactivated by FDA2026-08-11

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.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N011722-002TENUATEDIETHYLPROPION HYDROCHLORIDE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, 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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N011722-002TENUATE25MGTABLET / ORALAARLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N011722-002TENUATE25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N011722-002TENUATE25MGTABLET / ORALRLD, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07N011722-002AA1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
0029c986-f448-4e26-865d-441bd9700d12Product name120201013
a29cb53e-8fe0-4754-9013-e084b50c1c66Product name120170614

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
12634-530-00Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-01Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-09Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-12Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-18Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-40Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-42Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-45Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-50Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-52Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-54Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-57Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-59Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-60Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-61Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-63Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-66Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-67Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-69Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-71Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-74Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-78Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-79Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-80Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-81Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-82Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-84Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-85Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-90Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-91Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-92Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-93Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-94Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-95Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-96Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-97Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-98Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only
12634-530-99Diethylpropion HCl USP C-IV Immediate-Release 25 mg Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-530-00Diethylpropion Hydrochloride10 in 1 BOTTLETABLET103
12634-530-01Diethylpropion Hydrochloride100 in 1 BOTTLETABLET1003
12634-530-09Diethylpropion Hydrochloride35 in 1 BOTTLETABLET353
12634-530-12Diethylpropion Hydrochloride120 in 1 BOTTLETABLET1203
12634-530-18Diethylpropion Hydrochloride180 in 1 BOTTLETABLET1803
12634-530-40Diethylpropion Hydrochloride40 in 1 BOTTLETABLET403
12634-530-42Diethylpropion Hydrochloride42 in 1 BOTTLETABLET423
12634-530-45Diethylpropion Hydrochloride45 in 1 BOTTLETABLET453
12634-530-50Diethylpropion Hydrochloride50 in 1 BOTTLETABLET503
12634-530-52Diethylpropion Hydrochloride12 in 1 BLISTER PACKTABLET123
12634-530-54Diethylpropion Hydrochloride14 in 1 BLISTER PACKTABLET143
12634-530-57Diethylpropion Hydrochloride20 in 1 BLISTER PACKTABLET203
12634-530-59Diethylpropion Hydrochloride30 in 1 BLISTER PACKTABLET303
12634-530-60Diethylpropion Hydrochloride60 in 1 BOTTLETABLET603
12634-530-61Diethylpropion Hydrochloride10 in 1 BLISTER PACKTABLET103
12634-530-63Diethylpropion Hydrochloride3 in 1 BLISTER PACKTABLET33
12634-530-66Diethylpropion Hydrochloride6 in 1 BLISTER PACKTABLET63
12634-530-67Diethylpropion Hydrochloride7 in 1 BLISTER PACKTABLET73
12634-530-69Diethylpropion Hydrochloride9 in 1 BLISTER PACKTABLET93
12634-530-71Diethylpropion Hydrochloride30 in 1 BOTTLETABLET303
12634-530-74Diethylpropion Hydrochloride24 in 1 BOTTLETABLET243
12634-530-78Diethylpropion Hydrochloride28 in 1 BOTTLETABLET283
12634-530-79Diethylpropion Hydrochloride25 in 1 BOTTLETABLET253
12634-530-80Diethylpropion Hydrochloride20 in 1 BOTTLETABLET203
12634-530-81Diethylpropion Hydrochloride21 in 1 BOTTLETABLET213
12634-530-82Diethylpropion Hydrochloride12 in 1 BOTTLETABLET123
12634-530-84Diethylpropion Hydrochloride14 in 1 BOTTLETABLET143
12634-530-85Diethylpropion Hydrochloride15 in 1 BOTTLETABLET153
12634-530-90Diethylpropion Hydrochloride90 in 1 BOTTLETABLET903
12634-530-91Diethylpropion Hydrochloride1 in 1 BLISTER PACKTABLET13
12634-530-92Diethylpropion Hydrochloride2 in 1 BOTTLETABLET23
12634-530-93Diethylpropion Hydrochloride3 in 1 BOTTLETABLET33
12634-530-94Diethylpropion Hydrochloride4 in 1 BOTTLETABLET43
12634-530-95Diethylpropion Hydrochloride5 in 1 BOTTLETABLET53
12634-530-96Diethylpropion Hydrochloride6 in 1 BOTTLETABLET63
12634-530-97Diethylpropion Hydrochloride7 in 1 BOTTLETABLET73
12634-530-98Diethylpropion Hydrochloride8 in 1 BOTTLETABLET83
12634-530-99Diethylpropion Hydrochloride9 in 1 BOTTLETABLET93

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208DIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EDIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVDIETHYLPROPION HYDROCHLORIDE TABLET DIETHYLPROPION HYDROCHLORIDE ER TABLET [APOTHECA INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-530DIETHYLPROPION HYDROCHLORIDE TABLET [APOTHECA INC.]3Legacy NDC, 38 package rows20170124_0971fa2e-d660-48b0-9fbb-96a2db167b92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978654diethylpropion HCl 25 MG Oral TabletPSN0971fa2e-d660-48b0-9fbb-96a2db167b923
978654diethylpropion hydrochloride 25 MG Oral TabletSCD0971fa2e-d660-48b0-9fbb-96a2db167b923

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12634-530-091263405300935 TABLET in 1 BOTTLE (12634-530-09) 35 tablet2017-01-230000-00-00NoNoCurrent