FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
72789-433
11-digit product format
727890433
Labeler code
72789
Product ID
72789-433_47f6fb4d-1048-74df-e063-6394a90a5fa9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA200272
Marketing category
ANDA
Marketing start
2024-02-15
Marketing end
2028-04-30
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
37.5 mg/1
Pharmacologic classes
Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE37.5 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
32c2b0bd-1f13-4890-99e0-dcd2ea16e1abProduct name220230717
ebeae3eb-385d-62da-8827-5ffa80b14e90Product name220170810
1d682039-1122-1cb7-f3f4-c0a028b98748Product name420170124
8ef9ca65-1a6c-7225-351d-36066d0f8e56Product name320161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-433-07Phentermine Hydrochloride7 in 1 BOTTLE, PLASTICTABLET713
72789-433-14Phentermine Hydrochloride14 in 1 BOTTLE, PLASTICTABLET1413
72789-433-15Phentermine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET1513
72789-433-28Phentermine Hydrochloride28 in 1 BOTTLE, PLASTICTABLET2813
72789-433-30Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3013
72789-433-45Phentermine Hydrochloride45 in 1 BOTTLE, PLASTICTABLET4513
72789-433-60Phentermine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET6013
72789-433-90Phentermine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-433PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9Current NDC, 8 package rows20241109_19f1ce79-65f4-4bf4-a9ff-6ca0a131530f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-433-07727890433077 TABLET in 1 BOTTLE, PLASTIC (72789-433-07) 7 tablet2024-10-242028-04-30NoNoHistorical
72789-433-147278904331414 TABLET in 1 BOTTLE, PLASTIC (72789-433-14) 14 tablet2025-07-212028-04-30NoNoHistorical
72789-433-157278904331515 TABLET in 1 BOTTLE, PLASTIC (72789-433-15) 15 tablet2024-10-012028-04-30NoNoHistorical
72789-433-287278904332828 TABLET in 1 BOTTLE, PLASTIC (72789-433-28) 28 tablet2024-11-042028-04-30NoNoHistorical
72789-433-307278904333030 TABLET in 1 BOTTLE, PLASTIC (72789-433-30) 30 tablet2024-11-062028-04-30NoNoHistorical
72789-433-457278904334545 TABLET in 1 BOTTLE, PLASTIC (72789-433-45) 45 tablet2024-11-072028-04-30NoNoHistorical
72789-433-607278904336060 TABLET in 1 BOTTLE, PLASTIC (72789-433-60) 60 tablet2024-10-182028-04-30NoNoHistorical
72789-433-907278904339090 TABLET in 1 BOTTLE, PLASTIC (72789-433-90) 90 tablet2024-10-182028-04-30NoNoHistorical