Phentermine Hydrochloride

Product NDC
63629-8528
11-digit product format
636298528
Labeler code
63629
Product ID
63629-8528_35c91e1c-2b9d-4e6c-9395-63d73d77ce47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phentermine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205019
Marketing category
ANDA
Marketing start
2017-01-24
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
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 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
63629-8528-1Phentermine Hydrochloride1000 in 1 BOTTLECAPSULE1000103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8528PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240113_640d71d8-45c9-42fb-ad96-2f3ac60afc9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN640d71d8-45c9-42fb-ad96-2f3ac60afc9c103
968766phentermine hydrochloride 15 MG Oral CapsuleSCD640d71d8-45c9-42fb-ad96-2f3ac60afc9c103
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY640d71d8-45c9-42fb-ad96-2f3ac60afc9c103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8528-1636298528011000 CAPSULE in 1 BOTTLE (63629-8528-1) 1000 capsule2021-05-190000-00-00NoNoCurrent