FDA.reportPublic FDA data

Diethylpropion HydrochlorideER

Product NDC
33261-354
11-digit product format
332610354
Labeler code
33261
Product ID
33261-354_55fa3e3c-536a-4fba-8006-86f392a23ce7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diethylpropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA091680
Marketing category
ANDA
Marketing start
2011-10-24
Marketing end
0000-00-00
Substance
DIETHYLPROPION HYDROCHLORIDE
Active strength
75 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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-354IInactivated by FDA2026-07-31
excluded packagepackage33261-35433261-354-07IInactivated by FDA2026-07-31
excluded packagepackage33261-35433261-354-14IInactivated by FDA2026-07-31
excluded packagepackage33261-35433261-354-28IInactivated by FDA2026-07-31
excluded packagepackage33261-35433261-354-30IInactivated 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
A091680-001DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-24

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 22:54:322026-06A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-24a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEA-S Medication Solutions04f1a804-00f1-48f5-acfa-0ed1a85447842026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.0d213a24-ebbf-41df-8f32-de44a572829e2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEOMNIVIUM PHARMACEUTICALS LLC.cd4f2b19-8752-4fed-81f3-d3074ade613c2025-09-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDENuCare Pharmaceuticals, Inc.335265e0-1d5d-31fb-e063-6394a90a2e752025-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDECalvin Scott & Co., Inc.d6cde8cc-26ae-4087-8eac-b11192749cc52025-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
DIETHYLPROPION HYDROCHLORIDE ERDIETHYLPROPION HYDROCHLORIDE ERDirectrxd44e23db-381a-cfc3-e053-2995a90a13c82025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEChartwell RX, LLC.fdb6e69c-4f8e-42d8-bdda-c99ff3ad7c1e2024-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEBryant Ranch Prepack89306917-a65b-40d4-9c51-d59ac0ad20172024-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDELannett Company, Inc.dab53f4f-68d4-4477-a2b6-ad44a956332b2022-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEProficient Rx LP15110f70-6602-4e05-a4b5-716a86dcaed52019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
0029c986-f448-4e26-865d-441bd9700d12Product name120201013
a29cb53e-8fe0-4754-9013-e084b50c1c66Product name120170614
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-354-072020-01-31C16284748780-19d75b9d0-cd24-f424-e053-dadaa90a57ceDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
33261-354-142020-01-31C16284748780-19d75b9d0-cd24-f424-e053-dadaa90a57ceDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
33261-354-282020-01-31C16284748780-19d75b9d0-cd24-f424-e053-dadaa90a57ceDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
33261-354-302020-01-31C16284748780-19d75b9d0-cd24-f424-e053-dadaa90a57ceDiethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-354-07Diethylpropion HydrochlorideERER7 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE71
33261-354-14Diethylpropion HydrochlorideERER14 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE141
33261-354-28Diethylpropion HydrochlorideERER28 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE281
33261-354-30Diethylpropion HydrochlorideERER30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-354-07EA - Each33261-3546e2250e6-2479-487d-b1f2-8bf83229a1fb12015-10-02
33261-354-14EA - Each33261-354a4fe3089-714f-4a93-a4ed-fe0e5102173712015-10-02
33261-354-28EA - Each33261-354a38da3de-4c85-42de-8338-6fa9b80c82d912015-10-02
33261-354-30EA - Each33261-354155fabb9-1d0b-4953-9379-8df666a5528412015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTF68VH75CJCDIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WDIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-354DIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20140106_19cfb2fd-f657-4f97-9494-43b909967cfa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSN19cfb2fd-f657-4f97-9494-43b909967cfa1
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD19cfb2fd-f657-4f97-9494-43b909967cfa1
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSY19cfb2fd-f657-4f97-9494-43b909967cfa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-354-07332610354077 in 1 BOTTLE, PLASTICHistorical
33261-354-143326103541414 in 1 BOTTLE, PLASTICHistorical
33261-354-283326103542828 in 1 BOTTLE, PLASTICHistorical
33261-354-303326103543030 in 1 BOTTLE, PLASTICHistorical