Diethylpropion Hydrochloride

Product NDC
17224-760
11-digit product format
172240760
Labeler code
17224
Product ID
17224-760_2efc1ef8-67d5-08c4-e063-6394a90ab458
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIETHYLPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Calvin Scott & Co., Inc.
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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-243f01610625f2…
2019-09-15 20:21 UTC2019-09A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALAB2011-10-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALABRS2011-10-24cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091680-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091680-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091680-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091680-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091680-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091680-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091680-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091680-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091680-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091680-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091680-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091680-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091680-001AB1ea99ee380514…
2023-01-26 05:58 UTC2023-01A091680-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091680-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091680-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091680-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091680-001AB1cb3db0bc1861…

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
d6cde8cc-26ae-4087-8eac-b11192749cc5Available 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
17224-760-07Diethylpropion HydrochlorideER7 in 1 BOTTLETABLET, EXTENDED RELEASE72
17224-760-28Diethylpropion HydrochlorideER28 in 1 BOTTLETABLET, EXTENDED RELEASE282
17224-760-30Diethylpropion HydrochlorideER30 in 1 BOTTLETABLET, EXTENDED RELEASE302
17224-760-56Diethylpropion HydrochlorideER56 in 1 BOTTLETABLET, EXTENDED RELEASE562
17224-760-84Diethylpropion HydrochlorideER84 in 1 BOTTLETABLET, EXTENDED RELEASE842

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17224-760DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [CALVIN SCOTT & CO., INC.]2Current NDC, 5 package rows20250227_d6cde8cc-26ae-4087-8eac-b11192749cc5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
ndc (product): 17224-760
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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSNd6cde8cc-26ae-4087-8eac-b11192749cc52
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCDd6cde8cc-26ae-4087-8eac-b11192749cc52
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSYd6cde8cc-26ae-4087-8eac-b11192749cc52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
17224-760-07172240760077 TABLET, EXTENDED RELEASE in 1 BOTTLE (17224-760-07) 2011-10-24NoNoCurrent
17224-760-281722407602828 TABLET, EXTENDED RELEASE in 1 BOTTLE (17224-760-28) 2011-10-24NoNoCurrent
17224-760-301722407603030 TABLET, EXTENDED RELEASE in 1 BOTTLE (17224-760-30) 2011-10-24NoNoCurrent
17224-760-561722407605656 TABLET, EXTENDED RELEASE in 1 BOTTLE (17224-760-56) 2011-10-24NoNoCurrent
17224-760-841722407608484 TABLET, EXTENDED RELEASE in 1 BOTTLE (17224-760-84) 2011-10-24NoNoCurrent