FDA.reportPublic FDA data

Diethylpropion Hydrochloride

Product NDC
71335-0049
11-digit product format
713350049
Labeler code
71335
Product ID
71335-0049_c150ef3f-41d3-445b-b566-4d672759a1d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diethylpropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091680
Marketing category
ANDA
Marketing start
2011-10-24
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
2026-12-31
Current FDA listing
Yes

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
ndc (product): 71335-0049
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

Additional Listing Data#

Finished product
Yes
Brand name base
Diethylpropion Hydrochloride
Brand name suffix
ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIETHYLPROPION HYDROCHLORIDE75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19V2PL39NGInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
978668Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89306917-a65b-40d4-9c51-d59ac0ad2017Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0049-1Diethylpropion HydrochlorideER30 in 1 BOTTLETABLET, EXTENDED RELEASE3010
71335-0049-2Diethylpropion HydrochlorideER28 in 1 BOTTLETABLET, EXTENDED RELEASE2810
71335-0049-3Diethylpropion HydrochlorideER90 in 1 BOTTLETABLET, EXTENDED RELEASE9010
71335-0049-4Diethylpropion HydrochlorideER7 in 1 BOTTLETABLET, EXTENDED RELEASE710
71335-0049-5Diethylpropion HydrochlorideER14 in 1 BOTTLETABLET, EXTENDED RELEASE1410
71335-0049-6Diethylpropion HydrochlorideER84 in 1 BOTTLETABLET, EXTENDED RELEASE8410
71335-0049-7Diethylpropion HydrochlorideER21 in 1 BOTTLETABLET, EXTENDED RELEASE2110
71335-0049-8Diethylpropion HydrochlorideER60 in 1 BOTTLETABLET, EXTENDED RELEASE6010
71335-0049-9Diethylpropion HydrochlorideER45 in 1 BOTTLETABLET, EXTENDED RELEASE4510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0049-1EA - Each71335-0049424e7f70-22f8-416e-8def-eca7df5a111a12018-03-08
71335-0049-2EA - Each71335-0049ac79a0b5-a424-4a3a-915e-4c2ac506b84312018-03-08
71335-0049-3EA - Each71335-004976a1a2d5-9a68-44f2-a204-5fd577157ad212018-03-08
71335-0049-4EA - Each71335-004944989310-6f47-42b0-aaf7-034a889400e112018-03-08
71335-0049-5EA - Each71335-004991440c40-8e36-4df3-9c8b-d6ebd9d6dd6212018-03-08
71335-0049-6EA - Each71335-0049ee7714f4-ff75-4a2e-ae8c-d65f4caf186512018-03-08
71335-0049-7EA - Each71335-00494e7a37f6-887f-4c0d-a7de-75a5c44b5b2c12018-03-08
71335-0049-8EA - Each71335-0049a9bb91fa-c122-4f41-89a7-61fec54f92f512018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0049DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 9 package rows20240809_89306917-a65b-40d4-9c51-d59ac0ad2017.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSN89306917-a65b-40d4-9c51-d59ac0ad201710
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD89306917-a65b-40d4-9c51-d59ac0ad201710
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSY89306917-a65b-40d4-9c51-d59ac0ad201710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0049-17133500490130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-1) 2012-04-120000-00-00NoNoCurrent
71335-0049-27133500490228 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-2) 2012-04-120000-00-00NoNoCurrent
71335-0049-37133500490390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-3) 2012-04-120000-00-00NoNoCurrent
71335-0049-4713350049047 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-4) 2012-04-120000-00-00NoNoCurrent
71335-0049-57133500490514 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-5) 2012-04-120000-00-00NoNoCurrent
71335-0049-67133500490684 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-6) 2012-04-120000-00-00NoNoCurrent
71335-0049-77133500490721 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-7) 2012-04-120000-00-00NoNoCurrent
71335-0049-87133500490860 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-8) 2012-04-120000-00-00NoNoCurrent
71335-0049-97133500490945 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0049-9) 2012-04-120000-00-00NoNoCurrent