DIETHYLPROPION HYDROCHLORIDE

Product NDC
50090-0327
11-digit product format
500900327
Labeler code
50090
Product ID
50090-0327_cea24273-8f72-4e34-a942-0d967378b7df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIETHYLPROPION HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA201212
Marketing category
ANDA
Marketing start
2010-12-27
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
2026-12-31
Current FDA listing
Yes

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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-0327DDiscontinued by firm2026-08-17
excluded packagepackage50090-032750090-0327-0DDiscontinued by firm2026-08-17
excluded packagepackage50090-032750090-0327-3DDiscontinued by firm2026-08-17
excluded packagepackage50090-032750090-0327-4DDiscontinued by firm2026-08-17
excluded packagepackage50090-032750090-0327-5DDiscontinued by firm2026-08-17
excluded packagepackage50090-032750090-0327-7DDiscontinued by firm2026-08-17
excluded packagepackage50090-032750090-0327-8DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A201212-001DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A201212-001AA

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A201212-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201212-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201212-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201212-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201212-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201212-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201212-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201212-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201212-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201212-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201212-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201212-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201212-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201212-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201212-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201212-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201212-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201212-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201212-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201212-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201212-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201212-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A201212-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201212-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201212-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201212-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A201212-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201212-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201212-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201212-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201212-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201212-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201212-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201212-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201212-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A201212-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A201212-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201212-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201212-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201212-001AA1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
0029c986-f448-4e26-865d-441bd9700d12Product name120201013
a29cb53e-8fe0-4754-9013-e084b50c1c66Product name120170614

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0327-0DIETHYLPROPION HYDROCHLORIDE45 in 1 BOTTLETABLET4521
50090-0327-3DIETHYLPROPION HYDROCHLORIDE14 in 1 BOTTLETABLET1421
50090-0327-4DIETHYLPROPION HYDROCHLORIDE28 in 1 BOTTLETABLET2821
50090-0327-5DIETHYLPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET9021
50090-0327-7DIETHYLPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET6021
50090-0327-8DIETHYLPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET3021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0327-4EA - Each50090-032775d7ccc1-e866-4772-8355-8d7b6621775a12018-09-05
50090-0327-5EA - Each50090-0327ca02d3f7-110a-4187-9eb2-7cb726cd35cc12018-09-05
50090-0327-7EA - Each50090-0327c336bb8c-4ed9-4f12-a399-912090f1a02f12018-09-05
50090-0327-8EA - Each50090-0327f52c4717-7d22-426c-b510-44db37a4870d12018-09-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0327DIETHYLPROPION HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]21Current NDC, Legacy NDC, 6 package rows20230226_fca52c33-b2c9-46cb-affc-2d6d23730f37.zip

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.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ad0c3dc9-ae13-4853-bc8c-a66e2a69cc102025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201212
application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDEMartek Pharmacal Co.130511dc-8f01-02ca-e063-6394a90a671b2025-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201212
application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.335fb85d-8b1f-e648-e063-6294a90aa1582025-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201212
application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDECalvin Scott & Co., Inc.fa48ad75-4fc8-4355-a19d-cd1b9d87f5532025-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201212
application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.fe7e5022-8b58-aa4f-e053-6294a90af65e2025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201212
application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDEBryant Ranch Prepackfb8e2f1b-24ef-4e1d-a493-4c3b3de05b262024-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201212
application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDEKVK-TECH, INC3ecb7bd7-e04c-47fe-859a-8ba8a54f9aff2024-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201212
application number: ANDA201212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0327-05009003270045 TABLET in 1 BOTTLE (50090-0327-0) 45 tablet2018-11-010000-00-00NoNoCurrent
50090-0327-35009003270314 TABLET in 1 BOTTLE (50090-0327-3) 14 tablet2014-11-280000-00-00NoNoCurrent
50090-0327-45009003270428 TABLET in 1 BOTTLE (50090-0327-4) 28 tablet2014-11-280000-00-00NoNoCurrent
50090-0327-55009003270590 TABLET in 1 BOTTLE (50090-0327-5) 90 tablet2014-11-280000-00-00NoNoCurrent
50090-0327-75009003270760 TABLET in 1 BOTTLE (50090-0327-7) 60 tablet2014-11-280000-00-00NoNoCurrent
50090-0327-85009003270830 TABLET in 1 BOTTLE (50090-0327-8) 30 tablet2014-11-280000-00-00NoNoCurrent