FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
Unii6985IP0T80
Rxcui979549

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

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