PHENDIMETRAZINE TARTRATE

Product NDC
72989-409
11-digit product format
729890409
Labeler code
72989
Product ID
72989-409_72552285-ab14-4e9f-957a-d913b31bdd84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENDIMETRAZINE TARTRATE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Acertis Pharmaceuticals, LLC
Application
NDA018074
Marketing category
NDA
Marketing start
2022-11-01
Substance
PHENDIMETRAZINE TARTRATE
Active strength
105 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 TARTRATE105 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6985IP0T80
Rxcui979543

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
71525015-bcb9-5864-7749-4b5f528a6b6aProduct name220180419
977c925f-5460-67b1-e843-25a0ba370df1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72989-409-11PHENDIMETRAZINE TARTRATE1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10003
72989-409-30PHENDIMETRAZINE TARTRATE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72989-409-30EA - Each72989-409a2247a7f-80b7-476d-9823-f709ccd84c8b12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72989-409PHENDIMETRAZINE TARTRATE CAPSULE, EXTENDED RELEASE [ACERTIS PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 2 package rows20230826_162140d3-b833-4633-9759-95821a46a690.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979543phendimetrazine tartrate 105 MG 24HR Extended Release Oral CapsulePSN162140d3-b833-4633-9759-95821a46a6903
97954324 HR phendimetrazine tartrate 105 MG Extended Release Oral CapsuleSCD162140d3-b833-4633-9759-95821a46a6903
979543phendimetrazine 105 MG 24 HR Extended Release Oral CapsuleSY162140d3-b833-4633-9759-95821a46a6903

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72989-409-11729890409111000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72989-409-11) 2022-11-010000-00-00NoNoCurrent
72989-409-307298904093030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72989-409-30) 2022-11-010000-00-00NoNoCurrent