FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
63629-4385
11-digit product format
636294385
Labeler code
63629
Product ID
63629-4385_07e8afaf-c273-4f13-81fe-1065ec101e71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040876
Marketing category
ANDA
Marketing start
2012-08-15
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-4385-12021-08-17C16284748780-19855e2a2-36e4-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-22021-08-17C16284748780-19855e2a2-36e4-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-32021-08-17C16284748780-19855e2a2-36e4-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-42021-08-17C16284748780-19855e2a2-36e4-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-52021-08-17C16284748780-19855e2a2-36e4-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-62021-08-17C16284748780-19855e2a2-36e4-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-72021-08-17C16284748780-19855e2a2-36e4-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-12019-11-27C16284748780-19855e2a2-36e4-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-22019-11-27C16284748780-19855e2a2-36e4-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-32019-11-27C16284748780-19855e2a2-36e4-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-42019-11-27C16284748780-19855e2a2-36e4-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-52019-11-27C16284748780-19855e2a2-36e4-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-62019-11-27C16284748780-19855e2a2-36e4-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
63629-4385-72019-11-27C16284748780-19855e2a2-36e4-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4385-1Phentermine Hydrochloride7 in 1 BOTTLETABLET71009
63629-4385-2Phentermine Hydrochloride30 in 1 BOTTLETABLET301009
63629-4385-3Phentermine Hydrochloride14 in 1 BOTTLETABLET141009
63629-4385-4Phentermine Hydrochloride60 in 1 BOTTLETABLET601009
63629-4385-5Phentermine Hydrochloride28 in 1 BOTTLETABLET281009
63629-4385-6Phentermine Hydrochloride24 in 1 BOTTLETABLET241009
63629-4385-7Phentermine Hydrochloride45 in 1 BOTTLETABLET451009
63629-4385-8Phentermine Hydrochloride90 in 1 BOTTLETABLET901009
63629-4385-9Phentermine Hydrochloride21 in 1 BOTTLETABLET211009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4385-1EA - Each63629-43858c76eecf-1284-4e3f-a24c-51ff821c186a12025-08-11
63629-4385-2EA - Each63629-438503556005-a619-47cd-aa43-179bf640338012025-08-11
63629-4385-3EA - Each63629-43855654fc89-deff-4698-a72b-2912b30a7f3512025-08-11
63629-4385-6EA - Each63629-4385f9dbcb05-57ce-4af2-b6e7-5cb0c42d8f0312025-08-11
63629-4385-8EA - Each63629-43854d897521-1ef2-4194-8518-f5e6bde0259f12025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4385PHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1009Current NDC, Legacy NDC, 9 package rows20240821_2bd5487d-10da-4ae0-9105-273e1a5efdcb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN2bd5487d-10da-4ae0-9105-273e1a5efdcb1009
803353phentermine hydrochloride 37.5 MG Oral TabletSCD2bd5487d-10da-4ae0-9105-273e1a5efdcb1009
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY2bd5487d-10da-4ae0-9105-273e1a5efdcb1009

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4385-1636294385017 TABLET in 1 BOTTLE (63629-4385-1) 7 tablet2024-04-020000-00-00NoNoCurrent
63629-4385-26362943850230 TABLET in 1 BOTTLE (63629-4385-2) 30 tablet2024-04-020000-00-00NoNoCurrent
63629-4385-36362943850314 TABLET in 1 BOTTLE (63629-4385-3) 14 tablet2012-12-240000-00-00NoNoCurrent
63629-4385-46362943850460 TABLET in 1 BOTTLE (63629-4385-4) 60 tablet2024-04-020000-00-00NoNoCurrent
63629-4385-56362943850528 TABLET in 1 BOTTLE (63629-4385-5) 28 tablet2013-04-180000-00-00NoNoCurrent
63629-4385-66362943850624 TABLET in 1 BOTTLE (63629-4385-6) 24 tablet2013-03-220000-00-00NoNoCurrent
63629-4385-76362943850745 TABLET in 1 BOTTLE (63629-4385-7) 45 tablet2016-05-100000-00-00NoNoCurrent
63629-4385-86362943850890 TABLET in 1 BOTTLE (63629-4385-8) 90 tablet2020-12-040000-00-00NoNoCurrent
63629-4385-96362943850921 TABLET in 1 BOTTLE (63629-4385-9) 21 tablet2015-12-180000-00-00NoNoCurrent