FDA.reportPublic FDA data

Phentermine hydrochloride

Product NDC
72162-1228
11-digit product format
721621228
Labeler code
72162
Product ID
72162-1228_8fd85cc8-54f7-43d6-ba68-e9ed9b74247d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phentermine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205017
Marketing category
ANDA
Marketing start
2017-01-24
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui803348

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
72162-1228-0Phentermine hydrochloride1000 in 1 BOTTLECAPSULE1000105
72162-1228-1Phentermine hydrochloride100 in 1 BOTTLECAPSULE100105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1228-0EA - Each72162-1228871b84c5-af79-4c5c-b3d5-df313ce9225c12023-05-05
72162-1228-1EA - Each72162-1228a1dbb08d-33d6-4912-bfc8-c79c858b35ed12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1228PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, 2 package rows20240901_4686bc8d-7173-477e-96c8-a7d33653df2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803348phentermine HCl 37.5 MG Oral CapsulePSN4686bc8d-7173-477e-96c8-a7d33653df2e105
803348phentermine hydrochloride 37.5 MG Oral CapsuleSCD4686bc8d-7173-477e-96c8-a7d33653df2e105
803348phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral CapsuleSY4686bc8d-7173-477e-96c8-a7d33653df2e105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1228-0721621228001000 CAPSULE in 1 BOTTLE (72162-1228-0) 1000 capsule2023-04-21NoNoHistorical
72162-1228-172162122801100 CAPSULE in 1 BOTTLE (72162-1228-1) 100 capsule2023-04-21NoNoHistorical