FDA.reportPublic FDA data

DIETHYLPROPION HYDROCHLORIDE

Product NDC
50436-4164
11-digit product format
504364164
Labeler code
50436
Product ID
50436-4164_70fac393-0c33-43da-a152-61dfd38ae346
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIETHYLPROPION HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA201212
Marketing category
ANDA
Marketing start
2010-12-27
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
2019-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50436-4164IInactivated by FDA2026-07-31
excluded packagepackage50436-416450436-4164-1IInactivated by FDA2026-07-31
excluded packagepackage50436-416450436-4164-5IInactivated by FDA2026-07-31

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
50436-4164-12020-01-31C16284748780-19d75b9d0-04c9-f424-e053-dadaa90a57ceDiethylpropion HCl USP CIV 25 mg Tablets
50436-4164-52020-01-31C16284748780-19d75b9d0-04c9-f424-e053-dadaa90a57ceDiethylpropion HCl USP CIV 25 mg Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-4164-1DIETHYLPROPION HYDROCHLORIDE21 in 1 BOTTLETABLET213
50436-4164-5DIETHYLPROPION HYDROCHLORIDE100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-4164-1EA - Each50436-416405bb9816-9d48-4807-8f44-7f65dfeb0c2e12018-10-11
50436-4164-5EA - Each50436-4164deb9d299-90ed-425f-a156-f4627845818c12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIETHYLPROPION HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDIETHYLPROPION HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIETHYLPROPION HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-4164DIETHYLPROPION HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3Legacy NDC, 2 package rows20130516_31b58e5e-60af-4466-bd20-4b648e867e64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978654diethylpropion HCl 25 MG Oral TabletPSN31b58e5e-60af-4466-bd20-4b648e867e643
978654diethylpropion hydrochloride 25 MG Oral TabletSCD31b58e5e-60af-4466-bd20-4b648e867e643

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-4164-15043641640121 in 1 BOTTLEHistorical
50436-4164-550436416405100 in 1 BOTTLEHistorical