Phendimetrazine Tartrate

Product NDC
71335-0324
11-digit product format
713350324
Labeler code
71335
Product ID
71335-0324_e2bbffcf-c0cc-4dbc-b5e4-cdc5fd7cd0c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

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
1c2370fd-6b40-48dc-a42d-2488041d5b37Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0324-0Phendimetrazine Tartrate120 in 1 BOTTLETABLET12013
71335-0324-1Phendimetrazine Tartrate30 in 1 BOTTLETABLET3013
71335-0324-2Phendimetrazine Tartrate90 in 1 BOTTLETABLET9013
71335-0324-3Phendimetrazine Tartrate15 in 1 BOTTLETABLET1513
71335-0324-4Phendimetrazine Tartrate60 in 1 BOTTLETABLET6013
71335-0324-5Phendimetrazine Tartrate7 in 1 BOTTLETABLET713
71335-0324-6Phendimetrazine Tartrate21 in 1 BOTTLETABLET2113
71335-0324-7Phendimetrazine Tartrate42 in 1 BOTTLETABLET4213
71335-0324-8Phendimetrazine Tartrate100 in 1 BOTTLETABLET10013
71335-0324-9Phendimetrazine Tartrate28 in 1 BOTTLETABLET2813

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0324-0EA - Each71335-032423e95b5b-b685-4125-866a-6856e4384b8312025-08-11
71335-0324-1EA - Each71335-032426c4b66b-205e-4682-a904-18ef957951ff12019-08-06
71335-0324-2EA - Each71335-0324a5039020-d9f9-465e-b7fa-0241d0b07bbd12019-08-06
71335-0324-3EA - Each71335-0324c7e309e8-89c0-4852-994b-8d9e25437f1512019-08-06
71335-0324-4EA - Each71335-0324a8535c77-f03e-4acc-ba77-226468fe5d0612019-08-06
71335-0324-5EA - Each71335-0324304ba902-6fcf-4c60-87d5-bd1f245f15b812019-08-06
71335-0324-6EA - Each71335-0324e4e75ff7-0676-4546-a1cb-696859526bad12019-08-06
71335-0324-7EA - Each71335-03246f7bae0b-6a84-4028-854a-4ce95815c0af12019-08-06
71335-0324-8EA - Each71335-0324278d4c5f-c7bc-4ec0-9240-96aab38e056612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0324PHENDIMETRAZINE TARTRATE TABLET [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 10 package rows20240809_1c2370fd-6b40-48dc-a42d-2488041d5b37.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
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
ndc (product): 71335-0324
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 TabletPSN1c2370fd-6b40-48dc-a42d-2488041d5b3713
979549phendimetrazine tartrate 35 MG Oral TabletSCD1c2370fd-6b40-48dc-a42d-2488041d5b3713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0324-071335032400120 TABLET in 1 BOTTLE (71335-0324-0) 120 tablet2017-09-290000-00-00NoNoCurrent
71335-0324-17133503240130 TABLET in 1 BOTTLE (71335-0324-1) 30 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-27133503240290 TABLET in 1 BOTTLE (71335-0324-2) 90 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-37133503240315 TABLET in 1 BOTTLE (71335-0324-3) 15 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-47133503240460 TABLET in 1 BOTTLE (71335-0324-4) 60 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-5713350324057 TABLET in 1 BOTTLE (71335-0324-5) 7 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-67133503240621 TABLET in 1 BOTTLE (71335-0324-6) 21 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-77133503240742 TABLET in 1 BOTTLE (71335-0324-7) 42 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-871335032408100 TABLET in 1 BOTTLE (71335-0324-8) 100 tablet2011-04-260000-00-00NoNoCurrent
71335-0324-97133503240928 TABLET in 1 BOTTLE (71335-0324-9) 28 tablet2011-04-260000-00-00NoNoCurrent