Diethylpropion Hydrochloride

Product NDC
0527-1477
11-digit product format
005271477
Labeler code
0527
Product ID
0527-1477_425fc6fb-0240-4af6-83e4-3c7cb54c50e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diethylpropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lannett Company, 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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-24caaa826d4ba7…
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…

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
dab53f4f-68d4-4477-a2b6-ad44a956332bAvailable on FDA.report

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1477-01Diethylpropion HydrochlorideER100 in 1 BOTTLETABLET, EXTENDED RELEASE10018
0527-1477-25Diethylpropion HydrochlorideER250 in 1 BOTTLETABLET, EXTENDED RELEASE25018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1477-01EA - Each0527-14779958ad64-0793-4723-8686-b4bee9f16faa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
CARBOMER HOMOPOLYMER TYPE AINACTIVE INGREDIENTF68VH75CJCDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
CARBOMER HOMOPOLYMER TYPE AINACTIVE INGREDIENTF68VH75CJCDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]10
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
CARBOMER HOMOPOLYMER TYPE AINACTIVE INGREDIENTF68VH75CJCDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTF68VH75CJCDIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTF68VH75CJCDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WDIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDEER ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1477DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]18Current NDC, Legacy NDC, 2 package rows20240704_dab53f4f-68d4-4477-a2b6-ad44a956332b.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
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
ndc (product): 0527-1477
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 TabletPSN04f1a804-00f1-48f5-acfa-0ed1a854478429
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD04f1a804-00f1-48f5-acfa-0ed1a854478429
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSY04f1a804-00f1-48f5-acfa-0ed1a854478429
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSN0d213a24-ebbf-41df-8f32-de44a572829e28
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD0d213a24-ebbf-41df-8f32-de44a572829e28
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSY0d213a24-ebbf-41df-8f32-de44a572829e28
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSNdab53f4f-68d4-4477-a2b6-ad44a956332b18
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCDdab53f4f-68d4-4477-a2b6-ad44a956332b18
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSYdab53f4f-68d4-4477-a2b6-ad44a956332b18
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
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSN02478358-f606-4e58-a6eb-fa54bb77b9122
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSNd44e23db-381a-cfc3-e053-2995a90a13c82
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSNd6cde8cc-26ae-4087-8eac-b11192749cc52
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSN15110f70-6602-4e05-a4b5-716a86dcaed52
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCDd6cde8cc-26ae-4087-8eac-b11192749cc52
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD15110f70-6602-4e05-a4b5-716a86dcaed52
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD02478358-f606-4e58-a6eb-fa54bb77b9122
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCDd44e23db-381a-cfc3-e053-2995a90a13c82
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSYd6cde8cc-26ae-4087-8eac-b11192749cc52
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSY02478358-f606-4e58-a6eb-fa54bb77b9122
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSYd44e23db-381a-cfc3-e053-2995a90a13c82
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSY15110f70-6602-4e05-a4b5-716a86dcaed52
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSN335265e0-1d5d-31fb-e063-6394a90a2e751
978668diethylpropion HCl 75 MG 24HR Extended Release Oral TabletPSN19cfb2fd-f657-4f97-9494-43b909967cfa1
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD335265e0-1d5d-31fb-e063-6394a90a2e751
97866824 HR diethylpropion hydrochloride 75 MG Extended Release Oral TabletSCD19cfb2fd-f657-4f97-9494-43b909967cfa1
978668diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral TabletSY335265e0-1d5d-31fb-e063-6394a90a2e751
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-1477-0100527147701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-1477-01) 2011-10-240000-00-00NoNoCurrent
0527-1477-2500527147725250 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-1477-25) 2011-10-240000-00-00NoNoCurrent