FDA.reportPublic FDA data

Diethylpropion Hydrochloride

Product NDC
52959-329
11-digit product format
529590329
Labeler code
52959
Product ID
52959-329_76169420-9b18-7972-e053-2a91aa0ae241
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diethylpropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA091680
Marketing category
ANDA
Marketing start
2017-01-03
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-329IInactivated by FDA2026-07-31
excluded packagepackage52959-32952959-329-07IInactivated by FDA2026-07-31
excluded packagepackage52959-32952959-329-14IInactivated by FDA2026-07-31
excluded packagepackage52959-32952959-329-21IInactivated by FDA2026-07-31
excluded packagepackage52959-32952959-329-28IInactivated by FDA2026-07-31
excluded packagepackage52959-32952959-329-30IInactivated by FDA2026-07-31
excluded packagepackage52959-32952959-329-90IInactivated 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
0029c986-f448-4e26-865d-441bd9700d12Product name120201013
a29cb53e-8fe0-4754-9013-e084b50c1c66Product name120170614

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-329-072020-01-31C16284748780-19d75b9d0-6442-f424-e053-dadaa90a57ce0150/0329 DIETHYLPROPION
52959-329-142020-01-31C16284748780-19d75b9d0-6442-f424-e053-dadaa90a57ce0150/0329 DIETHYLPROPION
52959-329-212020-01-31C16284748780-19d75b9d0-6442-f424-e053-dadaa90a57ce0150/0329 DIETHYLPROPION
52959-329-282020-01-31C16284748780-19d75b9d0-6442-f424-e053-dadaa90a57ce0150/0329 DIETHYLPROPION
52959-329-302020-01-31C16284748780-19d75b9d0-6442-f424-e053-dadaa90a57ce0150/0329 DIETHYLPROPION
52959-329-902020-01-31C16284748780-19d75b9d0-6442-f424-e053-dadaa90a57ce0150/0329 DIETHYLPROPION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-329-07Diethylpropion Hydrochloride7 in 1 VIALTABLET, EXTENDED RELEASE74
52959-329-14Diethylpropion Hydrochloride14 in 1 VIALTABLET, EXTENDED RELEASE144
52959-329-21Diethylpropion Hydrochloride21 in 1 VIALTABLET, EXTENDED RELEASE214
52959-329-28Diethylpropion Hydrochloride28 in 1 VIALTABLET, EXTENDED RELEASE284
52959-329-30Diethylpropion Hydrochloride30 in 1 VIALTABLET, EXTENDED RELEASE304
52959-329-90Diethylpropion Hydrochloride90 in 1 VIALTABLET, EXTENDED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-329-14EA - Each52959-329473f7613-d94c-47b5-8bff-f15e12b38caf12018-10-11
52959-329-28EA - Each52959-329d0a4c385-b7c0-4879-b1f6-e983498ec1f812018-10-11
52959-329-30EA - Each52959-329910735c9-9a32-468d-9bea-6fa4160e7b0e12018-10-11
52959-329-90EA - Each52959-329e62c996a-38b0-4db6-a996-848705b427b212018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-329DIETHYLPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE DIETHYLPROPION HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]4Legacy NDC, 6 package rows20180918_5202715d-5955-3a12-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978654diethylpropion HCl 25 MG Oral TabletPSN5202715d-5955-3a12-e054-00144ff8d46c4
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSN5202715d-5955-3a12-e054-00144ff8d46c4
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD5202715d-5955-3a12-e054-00144ff8d46c4
978654diethylpropion hydrochloride 25 MG Oral TabletSCD5202715d-5955-3a12-e054-00144ff8d46c4
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSY5202715d-5955-3a12-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-329-07529590329077 in 1 VIALHistorical
52959-329-145295903291414 in 1 VIALHistorical
52959-329-215295903292121 in 1 VIALHistorical
52959-329-285295903292828 in 1 VIALHistorical
52959-329-305295903293030 in 1 VIALHistorical
52959-329-905295903299090 in 1 VIALHistorical