FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
53489-676
11-digit product format
534890676
Labeler code
53489
Product ID
53489-676_39e24c57-7266-2bf6-e063-6294a90afdd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA040526
Marketing category
ANDA
Marketing start
2013-08-12
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
53489-676-01Phentermine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10010
53489-676-03Phentermine Hydrochloride250 in 1 BOTTLE, PLASTICTABLET25010
53489-676-05Phentermine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET50010
53489-676-06Phentermine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET6010
53489-676-07Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3010
53489-676-10Phentermine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-676-01EA - Each53489-676dae2d297-9f54-4885-bb4d-db3c0663383e12013-10-17
53489-676-10EA - Each53489-67670d1e3f8-2494-4b6e-ad13-f8382437be4812013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
calcium phosphate, dibasic, dihydrateINACTIVE INGREDIENTO7TSZ97GEPPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
crospovidoneINACTIVE INGREDIENT68401960MKPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
magnesium stearateINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
povidonesINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
calcium phosphate, dibasic, dihydrateINACTIVE INGREDIENTO7TSZ97GEPPHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
crospovidoneINACTIVE INGREDIENT68401960MKPHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
povidonesINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]5
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
calcium phosphate, dibasic, dihydrateINACTIVE INGREDIENTO7TSZ97GEPPHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
crospovidoneINACTIVE INGREDIENT68401960MKPHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
povidonesINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]2
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-676PHENTERMINE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]9Current NDC, Legacy NDC, 6 package rows20200228_02b8f684-b1ca-4ab7-9567-bcacc6a92779.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN0e893b62-bb07-4984-9f0a-3601435fbc2714
803353phentermine hydrochloride 37.5 MG Oral TabletSCD0e893b62-bb07-4984-9f0a-3601435fbc2714
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY0e893b62-bb07-4984-9f0a-3601435fbc2714
803353phentermine HCl 37.5 MG Oral TabletPSN02b8f684-b1ca-4ab7-9567-bcacc6a9277910
803353phentermine hydrochloride 37.5 MG Oral TabletSCD02b8f684-b1ca-4ab7-9567-bcacc6a9277910
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY02b8f684-b1ca-4ab7-9567-bcacc6a9277910
803353phentermine HCl 37.5 MG Oral TabletPSNd1d74574-9ebc-45fc-86e9-8cbd59acacd44
803353phentermine hydrochloride 37.5 MG Oral TabletSCDd1d74574-9ebc-45fc-86e9-8cbd59acacd44
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYd1d74574-9ebc-45fc-86e9-8cbd59acacd44
803353phentermine HCl 37.5 MG Oral TabletPSNaa9d7161-cda3-4ded-8d5b-424abd1a66812
803353phentermine hydrochloride 37.5 MG Oral TabletSCDaa9d7161-cda3-4ded-8d5b-424abd1a66812
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYaa9d7161-cda3-4ded-8d5b-424abd1a66812
803353phentermine HCl 37.5 MG Oral TabletPSN4cec0e47-5373-2133-e063-6394a90a20091
803353phentermine hydrochloride 37.5 MG Oral TabletSCD4cec0e47-5373-2133-e063-6394a90a20091
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY4cec0e47-5373-2133-e063-6394a90a20091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53489-676-0153489067601100 TABLET in 1 BOTTLE, PLASTIC (53489-676-01) 100 tablet2013-08-120000-00-00NoNoCurrent
53489-676-0353489067603250 TABLET in 1 BOTTLE, PLASTIC (53489-676-03) 250 tablet2013-08-120000-00-00NoNoCurrent
53489-676-0553489067605500 TABLET in 1 BOTTLE, PLASTIC (53489-676-05) 500 tablet2013-08-120000-00-00NoNoCurrent
53489-676-065348906760660 TABLET in 1 BOTTLE, PLASTIC (53489-676-06) 60 tablet2013-08-120000-00-00NoNoCurrent
53489-676-075348906760730 TABLET in 1 BOTTLE, PLASTIC (53489-676-07) 30 tablet2013-08-120000-00-00NoNoCurrent
53489-676-10534890676101000 TABLET in 1 BOTTLE, PLASTIC (53489-676-10) 1000 tablet2013-08-120000-00-00NoNoCurrent