FDA.reportPublic FDA data

DIETHYLPROPION HYDROCHLORIDE

Product NDC
50090-0327
Requested package NDC
50090-0327-5
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-032750090-0327-5DDiscontinued by firm2026-07-31

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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201212-001AA1a50c72e98297…

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.

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

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0327-02023-02-06C16284748780-1f386c64a-34d6-0266-e053-dadaa90a7c1aDiethylpropion HCl USP CIV 25 mg Tablets Rx Only
50090-0327-32023-02-06C16284748780-1f386c64a-34d6-0266-e053-dadaa90a7c1aDiethylpropion HCl USP CIV 25 mg Tablets Rx Only
50090-0327-42023-02-06C16284748780-1f386c64a-34d6-0266-e053-dadaa90a7c1aDiethylpropion HCl USP CIV 25 mg Tablets Rx Only
50090-0327-52023-02-06C16284748780-1f386c64a-34d6-0266-e053-dadaa90a7c1aDiethylpropion HCl USP CIV 25 mg Tablets Rx Only
50090-0327-72023-02-06C16284748780-1f386c64a-34d6-0266-e053-dadaa90a7c1aDiethylpropion HCl USP CIV 25 mg Tablets Rx Only
50090-0327-82023-02-06C16284748780-1f386c64a-34d6-0266-e053-dadaa90a7c1aDiethylpropion HCl USP CIV 25 mg Tablets Rx Only
50090-0327-02023-01-30C16284748780-1f386c64a-34d6-0266-e053-dadaa90a7c1aDiethylpropion HCl USP CIV 25 mg Tablets Rx Only
50090-0327-32023-01-30C16284748780-1f386c64a-34d6-0266-e053-dadaa90a7c1aDiethylpropion HCl USP CIV 25 mg Tablets Rx Only
50090-0327-42023-01-30C16284748780-1f386c64a-34d6-0266-e053-dadaa90a7c1aDiethylpropion HCl USP CIV 25 mg Tablets Rx Only
50090-0327-52023-01-30C16284748780-1f386c64a-34d6-0266-e053-dadaa90a7c1aDiethylpropion HCl USP CIV 25 mg Tablets Rx Only
50090-0327-72023-01-30C16284748780-1f386c64a-34d6-0266-e053-dadaa90a7c1aDiethylpropion HCl USP CIV 25 mg Tablets Rx Only
50090-0327-82023-01-30C16284748780-1f386c64a-34d6-0266-e053-dadaa90a7c1aDiethylpropion HCl USP CIV 25 mg Tablets Rx Only

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIETHYLPROPION HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDIETHYLPROPION HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIETHYLPROPION HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0327-55009003270590 TABLET in 1 BOTTLE (50090-0327-5) 90 tablet2014-11-280000-00-00NoNoCurrent