Phentermine hydrochloride

Product NDC
63629-2389
11-digit product format
636292389
Labeler code
63629
Product ID
63629-2389_8f1a9664-2f64-44e7-8d86-44044b9c5944
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phentermine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205008
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
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
63629-2389-1Phentermine hydrochloride100 in 1 BOTTLETABLET100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2389-1EA - Each63629-23896f2b755e-5b17-4ce2-b3db-04c7f782aa6a12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2389PHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20250214_e0a6a289-7dbf-4b24-b815-46dee0d19fdc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNe0a6a289-7dbf-4b24-b815-46dee0d19fdc103
803353phentermine hydrochloride 37.5 MG Oral TabletSCDe0a6a289-7dbf-4b24-b815-46dee0d19fdc103
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYe0a6a289-7dbf-4b24-b815-46dee0d19fdc103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2389-163629238901100 TABLET in 1 BOTTLE (63629-2389-1) 100 tablet2017-01-240000-00-00NoNoCurrent