Diethylpropion Hydrochloride

Product NDC
0527-1475
11-digit product format
005271475
Labeler code
0527
Product ID
0527-1475_cafa73c7-2476-42ab-b1ac-2217aedd9e04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diethylpropion Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA200177
Marketing category
ANDA
Marketing start
2011-07-18
Substance
DIETHYLPROPION HYDROCHLORIDE
Active strength
25 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
A200177-001DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A200177-001AA

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 06:07:402026-07A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-183f01610625f2…
2019-09-15 20:21 UTC2019-09A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2011-07-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200177-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAARS2011-07-18e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A200177-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200177-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200177-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200177-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200177-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200177-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200177-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200177-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200177-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200177-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200177-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200177-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200177-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200177-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200177-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200177-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200177-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200177-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200177-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200177-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200177-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200177-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A200177-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200177-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200177-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200177-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A200177-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A200177-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200177-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200177-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200177-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200177-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200177-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200177-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200177-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A200177-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A200177-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200177-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200177-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200177-001AA1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIETHYLPROPION HYDROCHLORIDE25 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
978654Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4fdbc049-6497-4ea0-8788-d2b2963328f7Available 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0527-1475-012024-01-30C16284748780-11030e365-3bb4-111a-e063-dadaa90a10e2Diethylpropion Hydrochloride Tablets USP, 25 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1475-01Diethylpropion Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1475-01EA - Each0527-14757b1ced33-e44f-4682-ad5b-11e11f0d102312012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1475DIETHYLPROPION HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]14Current NDC, Legacy NDC, 1 package rows20240704_4fdbc049-6497-4ea0-8788-d2b2963328f7.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diethylpropion HydrochlorideDIETHYLPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5777eed8-c63d-49c4-9dd1-9d087906c3682025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200177
application number: ANDA200177
Diethylpropion HydrochlorideDIETHYLPROPION HYDROCHLORIDEA-S Medication Solutions7f4eca5b-f850-44fc-88b4-4d9bcdf2ba442025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200177
application number: ANDA200177
Diethylpropion HydrochlorideDIETHYLPROPION HYDROCHLORIDEChartwell RX, LLC.b8984c2d-244e-4c56-be3e-c402dc679b1f2024-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200177
application number: ANDA200177
Diethylpropion HydrochlorideDIETHYLPROPION HYDROCHLORIDEBryant Ranch Prepack54655904-7ce2-49d5-9acf-81ad9680d2152024-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200177
application number: ANDA200177
Diethylpropion HydrochlorideDIETHYLPROPION HYDROCHLORIDEProficient Rx LP2a2fbc1b-6430-485b-b581-10fbfca0af882020-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200177
application number: ANDA200177
Diethylpropion HydrochlorideDIETHYLPROPION HYDROCHLORIDELannett Company, Inc.4fdbc049-6497-4ea0-8788-d2b2963328f72019-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200177
application number: ANDA200177
ndc (product): 0527-1475

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978654diethylpropion HCl 25 MG Oral TabletPSN5777eed8-c63d-49c4-9dd1-9d087906c36819
978654diethylpropion hydrochloride 25 MG Oral TabletSCD5777eed8-c63d-49c4-9dd1-9d087906c36819
978654diethylpropion HCl 25 MG Oral TabletPSN4fdbc049-6497-4ea0-8788-d2b2963328f714
978654diethylpropion hydrochloride 25 MG Oral TabletSCD4fdbc049-6497-4ea0-8788-d2b2963328f714
978654diethylpropion HCl 25 MG Oral TabletPSN7f4eca5b-f850-44fc-88b4-4d9bcdf2ba4410
978654diethylpropion hydrochloride 25 MG Oral TabletSCD7f4eca5b-f850-44fc-88b4-4d9bcdf2ba4410
978654diethylpropion HCl 25 MG Oral TabletPSN2a2fbc1b-6430-485b-b581-10fbfca0af884
978654diethylpropion HCl 25 MG Oral TabletPSN54655904-7ce2-49d5-9acf-81ad9680d2154
978654diethylpropion hydrochloride 25 MG Oral TabletSCD2a2fbc1b-6430-485b-b581-10fbfca0af884
978654diethylpropion hydrochloride 25 MG Oral TabletSCD54655904-7ce2-49d5-9acf-81ad9680d2154
978654diethylpropion HCl 25 MG Oral TabletPSN66b079af-5764-413e-ab00-aa6a9b07d0b62
978654diethylpropion hydrochloride 25 MG Oral TabletSCD66b079af-5764-413e-ab00-aa6a9b07d0b62
978654diethylpropion HCl 25 MG Oral TabletPSN90ffecff-dd4d-4325-b3d9-ba39d36329191
978654diethylpropion hydrochloride 25 MG Oral TabletSCD90ffecff-dd4d-4325-b3d9-ba39d36329191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1475-0100527147501100 TABLET in 1 BOTTLE, PLASTIC (0527-1475-01) 100 tablet2011-07-180000-00-00NoNoCurrent