Phendimetrazine Tartrate

Product NDC
43063-510
11-digit product format
430630510
Labeler code
43063
Product ID
43063-510_2b33c59d-56f9-8ed2-e063-6394a90a1ad6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phendimetrazine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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 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
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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091042-001PHENDIMETRAZINE TARTRATE35MGTABLET / ORALAA2010-08-31caaa826d4ba7…
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…

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 06:07:402026-07A091042-001AA1caaa826d4ba7…
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…

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
467ae7d7-e342-423b-be89-5d38c1abf3c9Available 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
43063-510-07Phendimetrazine Tartrate7 in 1 BOTTLE, PLASTICTABLET720
43063-510-14Phendimetrazine Tartrate14 in 1 BOTTLE, PLASTICTABLET1420
43063-510-28Phendimetrazine Tartrate28 in 1 BOTTLE, PLASTICTABLET2820
43063-510-30Phendimetrazine Tartrate30 in 1 BOTTLE, PLASTICTABLET3020
43063-510-42Phendimetrazine Tartrate42 in 1 BOTTLE, PLASTICTABLET4220
43063-510-56Phendimetrazine Tartrate56 in 1 BOTTLE, PLASTICTABLET5620
43063-510-60Phendimetrazine Tartrate60 in 1 BOTTLE, PLASTICTABLET6020
43063-510-81Phendimetrazine Tartrate135 in 1 BOTTLE, PLASTICTABLET13520
43063-510-88Phendimetrazine Tartrate112 in 1 BOTTLE, PLASTICTABLET11220
43063-510-90Phendimetrazine Tartrate90 in 1 BOTTLE, PLASTICTABLET9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-510-07EA - Each43063-5100eb06b71-b911-4f6e-b9c4-032b414387fc12017-08-11
43063-510-14EA - Each43063-5103129c33d-8e5a-478e-a225-4af783389c6b12017-05-03
43063-510-28EA - Each43063-510dba61e1f-8ff8-4f5f-9b92-603bb1c9db2712017-05-03
43063-510-30EA - Each43063-510d2a8eb15-97a0-451d-a1b8-d6d3cf40279112014-08-01
43063-510-42EA - Each43063-510bffed9b3-d241-41de-bc25-b4e20765784812023-12-05
43063-510-56EA - Each43063-510629b9f9a-f2bd-42d9-a51b-9b2b4f7acb0812017-08-11
43063-510-60EA - Each43063-510fcdc843b-ddd5-46cc-a50e-948be9f1054612014-08-01
43063-510-81EA - Each43063-510cb490f0c-ae32-42e6-9106-cae04a6fcad712018-06-11
43063-510-88EA - Each43063-5105b460a2f-415a-43f7-971b-6a2f50fd72d912017-05-03
43063-510-90EA - Each43063-510d2d2eb5f-30fb-4369-bc50-e044d0d3efdb12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENDIMETRAZINE TARTRATEACTIVE INGREDIENT6985IP0T80PHENDIMETRAZINE TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]3
PHENDIMETRAZINEACTIVE MOIETYAB2794W8KVPHENDIMETRAZINE TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENDIMETRAZINE TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]3
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MPHENDIMETRAZINE TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENDIMETRAZINE TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENDIMETRAZINE TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENDIMETRAZINE TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PHENDIMETRAZINE TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-510PHENDIMETRAZINE TARTRATE TABLET [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 10 package rows20250110_467ae7d7-e342-423b-be89-5d38c1abf3c9.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 TARTRATEPreferred Pharmaceuticals Inc.767b5386-1e56-4eeb-8d59-510b940ab75e2026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091042
application number: ANDA091042
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 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
ndc (product): 43063-510
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 TabletPSN467ae7d7-e342-423b-be89-5d38c1abf3c920
979549phendimetrazine tartrate 35 MG Oral TabletSCD467ae7d7-e342-423b-be89-5d38c1abf3c920

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-510-07430630510077 TABLET in 1 BOTTLE, PLASTIC (43063-510-07) 7 tablet2017-06-230000-00-00NoNoCurrent
43063-510-144306305101414 TABLET in 1 BOTTLE, PLASTIC (43063-510-14) 14 tablet2017-04-110000-00-00NoNoCurrent
43063-510-284306305102828 TABLET in 1 BOTTLE, PLASTIC (43063-510-28) 28 tablet2010-09-150000-00-00NoNoCurrent
43063-510-304306305103030 TABLET in 1 BOTTLE, PLASTIC (43063-510-30) 30 tablet2010-09-150000-00-00NoNoCurrent
43063-510-424306305104242 TABLET in 1 BOTTLE, PLASTIC (43063-510-42) 42 tablet2023-10-06NoNoCurrent
43063-510-564306305105656 TABLET in 1 BOTTLE, PLASTIC (43063-510-56) 56 tablet2017-06-230000-00-00NoNoCurrent
43063-510-604306305106060 TABLET in 1 BOTTLE, PLASTIC (43063-510-60) 60 tablet2010-09-150000-00-00NoNoCurrent
43063-510-8143063051081135 TABLET in 1 BOTTLE, PLASTIC (43063-510-81) 135 tablet2018-05-010000-00-00NoNoCurrent
43063-510-8843063051088112 TABLET in 1 BOTTLE, PLASTIC (43063-510-88) 112 tablet2017-04-190000-00-00NoNoCurrent
43063-510-904306305109090 TABLET in 1 BOTTLE, PLASTIC (43063-510-90) 90 tablet2017-04-190000-00-00NoNoCurrent