FDA.reportPublic FDA data

PHENTERMINE HYDROCHLORIDE

Product NDC
72189-301
11-digit product format
721890301
Labeler code
72189
Product ID
72189-301_2c294c54-3c44-a9ae-e063-6294a90a2d90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DirectRx
Application
ANDA040876
Marketing category
ANDA
Marketing start
2021-12-06
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PHENTERMINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui803353

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
72189-301-14PHENTERMINE HYDROCHLORIDE14 in 1 BOTTLETABLET143
72189-301-30PHENTERMINE HYDROCHLORIDE30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-301PHENTERMINE HYDROCHLORIDE TABLET [DIRECTRX]3Current NDC, Legacy NDC, 2 package rows20250121_d27d8379-aa3c-4688-e053-2995a90a44f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNd27d8379-aa3c-4688-e053-2995a90a44f63
803353phentermine hydrochloride 37.5 MG Oral TabletSCDd27d8379-aa3c-4688-e053-2995a90a44f63
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYd27d8379-aa3c-4688-e053-2995a90a44f63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-301-147218903011414 TABLET in 1 BOTTLE (72189-301-14) 14 tablet2021-12-060000-00-00NoNoCurrent
72189-301-307218903013030 TABLET in 1 BOTTLE (72189-301-30) 30 tablet2021-12-060000-00-00NoNoCurrent