PHENDIMETRAZINE TARTRATE

Product NDC
69543-410
11-digit product format
695430410
Labeler code
69543
Product ID
69543-410_dc927d6a-f5b4-45e8-a732-c47831036d39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENDIMETRAZINE TARTRATE
Dosage form
TABLET
Route
ORAL
Labeler
Virtus Pharmaceuticals, LLC
Application
ANDA085588
Marketing category
ANDA
Marketing start
2018-07-01
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
69543-410-10PHENDIMETRAZINE TARTRATE100 in 1 BOTTLETABLET1004
69543-410-11PHENDIMETRAZINE TARTRATE1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-410-10EA - Each69543-4103d6785d5-31f1-4e61-bb80-032708238a4812018-08-13
69543-410-11EA - Each69543-4108cf1bec4-2692-4008-bf35-618e58b2917012018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69543-410PHENDIMETRAZINE TARTRATE TABLET [VIRTUS PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 2 package rows20241212_cc9a0cd2-6fb9-47ab-8e39-146d2fa361c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979549phendimetrazine tartrate 35 MG Oral TabletPSN75f6c4bc-ed72-498a-822c-ecc2a13df958104
979549phendimetrazine tartrate 35 MG Oral TabletSCD75f6c4bc-ed72-498a-822c-ecc2a13df958104
979549phendimetrazine tartrate 35 MG Oral TabletPSN137e5fcd-9536-4fb9-9885-5dfd1127c35a101
979549phendimetrazine tartrate 35 MG Oral TabletSCD137e5fcd-9536-4fb9-9885-5dfd1127c35a101
979549phendimetrazine tartrate 35 MG Oral TabletPSNcc9a0cd2-6fb9-47ab-8e39-146d2fa361c24
979549phendimetrazine tartrate 35 MG Oral TabletPSNd3c58ccf-0099-ed13-e053-2a95a90a4daa4
979549phendimetrazine tartrate 35 MG Oral TabletSCDcc9a0cd2-6fb9-47ab-8e39-146d2fa361c24
979549phendimetrazine tartrate 35 MG Oral TabletSCDd3c58ccf-0099-ed13-e053-2a95a90a4daa4
979549phendimetrazine tartrate 35 MG Oral TabletPSN577d69c4-35ae-4c2a-b707-b5b353c91b352
979549phendimetrazine tartrate 35 MG Oral TabletSCD577d69c4-35ae-4c2a-b707-b5b353c91b352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69543-410-1069543041010100 TABLET in 1 BOTTLE (69543-410-10) 100 tablet2018-07-010000-00-00NoNoCurrent
69543-410-11695430410111000 TABLET in 1 BOTTLE (69543-410-11) 1000 tablet2018-07-012026-09-30NoNoCurrent