FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
17224-901
11-digit product format
172240901
Labeler code
17224
Product ID
17224-901_4a195805-16d2-9214-e063-6394a90ac691
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Calvin Scott & Co., 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride
Listing expiration
2027-12-31

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
17224-901-07Phentermine Hydrochloride7 in 1 BOTTLE, PLASTICTABLET72
17224-901-14Phentermine Hydrochloride14 in 1 BOTTLE, PLASTICTABLET142
17224-901-28Phentermine Hydrochloride28 in 1 BOTTLE, PLASTICTABLET282
17224-901-30Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
17224-901-45Phentermine Hydrochloride45 in 1 BOTTLE, PLASTICTABLET452
17224-901-60Phentermine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602
17224-901-90Phentermine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17224-901PHENTERMINE HYDROCHLORIDE TABLET [CALVIN SCOTT & CO., INC.]1Current NDC, 7 package rows20250523_aa9d7161-cda3-4ded-8d5b-424abd1a6681.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17224-901-07172240901077 TABLET in 1 BOTTLE, PLASTIC (17224-901-07) 7 tablet2013-08-12NoNoCurrent
17224-901-141722409011414 TABLET in 1 BOTTLE, PLASTIC (17224-901-14) 14 tablet2013-08-12NoNoCurrent
17224-901-281722409012828 TABLET in 1 BOTTLE, PLASTIC (17224-901-28) 28 tablet2013-08-12NoNoCurrent
17224-901-301722409013030 TABLET in 1 BOTTLE, PLASTIC (17224-901-30) 30 tablet2013-08-12NoNoCurrent
17224-901-451722409014545 TABLET in 1 BOTTLE, PLASTIC (17224-901-45) 45 tablet2013-08-12NoNoCurrent
17224-901-601722409016060 TABLET in 1 BOTTLE, PLASTIC (17224-901-60) 60 tablet2013-08-12NoNoCurrent
17224-901-901722409019090 TABLET in 1 BOTTLE, PLASTIC (17224-901-90) 90 tablet2013-08-12NoNoCurrent