FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
72162-2312
11-digit product format
721622312
Labeler code
72162
Product ID
72162-2312_4bb667bf-b233-45e8-a46c-198f7d285a0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202248
Marketing category
ANDA
Marketing start
2024-02-15
Marketing end
2028-04-30
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
15 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 HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui968766

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
72162-2312-0Phentermine Hydrochloride1000 in 1 BOTTLECAPSULE1000103
72162-2312-1Phentermine Hydrochloride100 in 1 BOTTLECAPSULE100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2312-0EA - Each72162-23129bfbad7e-23db-4010-bdbb-de9aa448884d12024-06-10
72162-2312-1EA - Each72162-2312990f2e52-ad7b-47e5-ae6f-01cd78fcbf7b12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2312PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20250223_e48feec6-50c9-4ccd-b9da-56956d14c853.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSNe48feec6-50c9-4ccd-b9da-56956d14c853103
968766phentermine hydrochloride 15 MG Oral CapsuleSCDe48feec6-50c9-4ccd-b9da-56956d14c853103
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYe48feec6-50c9-4ccd-b9da-56956d14c853103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72162-2312-0721622312001000 CAPSULE in 1 BOTTLE (72162-2312-0) 1000 capsule2024-02-152028-04-30NoNoHistorical
72162-2312-172162231201100 CAPSULE in 1 BOTTLE (72162-2312-1) 100 capsule2024-02-152028-04-30NoNoHistorical