Phendimetrazine Tartrate

Product NDC
50090-0715
Requested package NDC
50090-0715-7
11-digit product format
500900715
Labeler code
50090
Product ID
50090-0715_04c270db-a517-4b1a-a6b9-b1eda68fcc7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091042
Marketing category
ANDA
Marketing start
2010-09-15
Substance
PHENDIMETRAZINE TARTRATE
Active strength
35 mg/1
Pharmacologic classes
Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-071550090-0715-7DDiscontinued by firm2026-08-07

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 · 2 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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-071550090-0715-7DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-071550090-0715-7DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A091042-001PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091042-001AA

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 UTC2026-02A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-313f01610625f2…
2019-09-15 20:21 UTC2019-09A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31cb3db0bc1861…

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 UTC2026-02A091042-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091042-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091042-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091042-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091042-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091042-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091042-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091042-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091042-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091042-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091042-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091042-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091042-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091042-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091042-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091042-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091042-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091042-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091042-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091042-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091042-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A091042-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091042-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091042-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091042-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A091042-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091042-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091042-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091042-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091042-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091042-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091042-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091042-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091042-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091042-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091042-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091042-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091042-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091042-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091042-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Phendimetrazine Tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENDIMETRAZINE TARTRATE35 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6985IP0T80Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
979549Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f1d265e1-522e-4a62-afda-29477fb94b8dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
71525015-bcb9-5864-7749-4b5f528a6b6aProduct name220180419
977c925f-5460-67b1-e843-25a0ba370df1Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0715-0Phendimetrazine Tartrate30 in 1 BOTTLETABLET3027
50090-0715-1Phendimetrazine Tartrate60 in 1 BOTTLETABLET6027
50090-0715-2Phendimetrazine Tartrate90 in 1 BOTTLETABLET9027
50090-0715-6Phendimetrazine Tartrate28 in 1 BOTTLETABLET2827
50090-0715-7Phendimetrazine Tartrate84 in 1 BOTTLETABLET8427
50090-0715-9Phendimetrazine Tartrate112 in 1 BOTTLETABLET11227

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0715-0EA - Each50090-07151515d97b-9552-47bc-8f42-457651329a7712018-10-11
50090-0715-1EA - Each50090-071534a62d15-a105-4fe7-ba63-950748a4c04312018-10-11
50090-0715-2EA - Each50090-0715a948f9ac-1e8c-4fa8-a75b-1c033b68839d12018-10-11
50090-0715-6EA - Each50090-0715260e30cf-3ff5-4dde-9062-686d584a294312018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENDIMETRAZINE TARTRATEACTIVE INGREDIENT6985IP0T80PHENDIMETRAZINE TARTRATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
PHENDIMETRAZINEACTIVE MOIETYAB2794W8KVPHENDIMETRAZINE TARTRATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENDIMETRAZINE TARTRATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MPHENDIMETRAZINE TARTRATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENDIMETRAZINE TARTRATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENDIMETRAZINE TARTRATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENDIMETRAZINE TARTRATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PHENDIMETRAZINE TARTRATE TABLET [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0715PHENDIMETRAZINE TARTRATE TABLET [A-S MEDICATION SOLUTIONS]27Current NDC, Legacy NDC, 6 package rows20250406_f1d265e1-522e-4a62-afda-29477fb94b8d.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
Phendimetrazine TartratePHENDIMETRAZINE TARTRATECalvin Scott & Co., Inc.f5c30a88-5814-5b42-e053-2995a90a437a2026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEA-S Medication Solutionsef4cfd54-7d3e-4571-ae77-38ab2fd1af3d2026-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEPreferred Pharmaceuticals Inc.767b5386-1e56-4eeb-8d59-510b940ab75e2025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
Phendimetrazine TartratePHENDIMETRAZINE TARTRATENuCare Pharmaceuticals, Inc.342bc2a2-2751-b51a-e063-6394a90a4c432025-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEA-S Medication Solutionsf1d265e1-522e-4a62-afda-29477fb94b8d2025-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
ndc (package): 50090-0715-7
ndc (product): 50090-0715
ndc11 (package): 50090071507
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEPD-Rx Pharmaceuticals, Inc.467ae7d7-e342-423b-be89-5d38c1abf3c92025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEKVK-TECH, INC07bf3488-09e7-436f-af3f-94c35a7be0252024-12-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
Phendimetrazine TartratePHENDIMETRAZINE TARTRATENuCare Pharmaceuticals, Inc,40e5b0bf-347e-30f6-e054-00144ff88e882024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEBryant Ranch Prepack1c2370fd-6b40-48dc-a42d-2488041d5b372024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
Phendimetrazine TartratePHENDIMETRAZINE TARTRATEA-S Medication Solutions7adaf128-fef4-4bbf-8b4a-875fe46bf68a2023-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979549phendimetrazine tartrate 35 MG Oral TabletPSNf1d265e1-522e-4a62-afda-29477fb94b8d27
979549phendimetrazine tartrate 35 MG Oral TabletSCDf1d265e1-522e-4a62-afda-29477fb94b8d27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0715-75009007150784 TABLET in 1 BOTTLE (50090-0715-7) 84 tablet2014-11-140000-00-00NoNoCurrent