FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
72162-1562
11-digit product format
721621562
Labeler code
72162
Product ID
72162-1562_d7c5de39-2416-4cc7-8b34-5283df8aaca1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200272
Marketing category
ANDA
Marketing start
2011-03-08
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
72162-1562-0Phentermine Hydrochloride1000 in 1 BOTTLETABLET1000102
72162-1562-1Phentermine Hydrochloride100 in 1 BOTTLETABLET100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1562-0EA - Each72162-1562a9bd74e4-2445-4f39-89d3-0aff48b4f47112024-01-04
72162-1562-1EA - Each72162-1562effe2dba-8fa6-4a61-883a-05458aafc3ff12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1562PHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20231010_707af68e-1630-4f86-87ba-1a643d2b4ef9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN707af68e-1630-4f86-87ba-1a643d2b4ef9102
803353phentermine hydrochloride 37.5 MG Oral TabletSCD707af68e-1630-4f86-87ba-1a643d2b4ef9102
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY707af68e-1630-4f86-87ba-1a643d2b4ef9102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1562-0721621562001000 TABLET in 1 BOTTLE (72162-1562-0) 1000 tablet2023-09-13NoNoHistorical
72162-1562-172162156201100 TABLET in 1 BOTTLE (72162-1562-1) 100 tablet2023-09-13NoNoHistorical