DIETHYLPROPION HYDROCHLORIDE

Product NDC
68071-3400
Requested package NDC
68071-3400-4
11-digit product format
680713400
Labeler code
68071
Product ID
68071-3400_2d54077e-4c8e-aaae-e063-6394a90adb41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIETHYLPROPION HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA201212
Marketing category
ANDA
Marketing start
2010-12-27
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-340068071-3400-4UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-340068071-3400-4UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-340068071-3400-4UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
A201212-001DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201212-001AA

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 · 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 UTC2026-02A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201212-001DIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALAA2010-12-22cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201212-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201212-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201212-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201212-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201212-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201212-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201212-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201212-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201212-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201212-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201212-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201212-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201212-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201212-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201212-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201212-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201212-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201212-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201212-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201212-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201212-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A201212-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201212-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201212-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201212-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A201212-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201212-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201212-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201212-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201212-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201212-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201212-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201212-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201212-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A201212-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A201212-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201212-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201212-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201212-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201212-001AA1cb3db0bc1861…

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
fe7e5022-8b58-aa4f-e053-6294a90af65eAvailable 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3400-0DIETHYLPROPION HYDROCHLORIDE112 in 1 BOTTLETABLET1124
68071-3400-1DIETHYLPROPION HYDROCHLORIDE21 in 1 BOTTLETABLET214
68071-3400-2DIETHYLPROPION HYDROCHLORIDE42 in 1 BOTTLETABLET424
68071-3400-3DIETHYLPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET304
68071-3400-4DIETHYLPROPION HYDROCHLORIDE84 in 1 BOTTLETABLET844
68071-3400-5DIETHYLPROPION HYDROCHLORIDE56 in 1 BOTTLETABLET564
68071-3400-7DIETHYLPROPION HYDROCHLORIDE14 in 1 BOTTLETABLET144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3400DIETHYLPROPION HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, 7 package rows20250206_fe7e5022-8b58-aa4f-e053-6294a90af65e.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ad0c3dc9-ae13-4853-bc8c-a66e2a69cc102025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201212
application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDEMartek Pharmacal Co.130511dc-8f01-02ca-e063-6394a90a671b2025-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201212
application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.335fb85d-8b1f-e648-e063-6294a90aa1582025-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201212
application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDECalvin Scott & Co., Inc.fa48ad75-4fc8-4355-a19d-cd1b9d87f5532025-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201212
application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.fe7e5022-8b58-aa4f-e053-6294a90af65e2025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201212
application number: ANDA201212
ndc (package): 68071-3400-4
ndc (product): 68071-3400
ndc11 (package): 68071340004
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDEBryant Ranch Prepackfb8e2f1b-24ef-4e1d-a493-4c3b3de05b262024-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201212
application number: ANDA201212
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDEKVK-TECH, INC3ecb7bd7-e04c-47fe-859a-8ba8a54f9aff2024-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201212
application number: ANDA201212

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978654diethylpropion HCl 25 MG Oral TabletPSNfe7e5022-8b58-aa4f-e053-6294a90af65e4
978654diethylpropion hydrochloride 25 MG Oral TabletSCDfe7e5022-8b58-aa4f-e053-6294a90af65e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3400-46807134000484 TABLET in 1 BOTTLE (68071-3400-4) 84 tablet2023-06-19NoNoCurrent