FDA.reportPublic FDA data

Phentermine hydrochloride

Product NDC
17224-904
11-digit product format
172240904
Labeler code
17224
Product ID
17224-904_f6e232c2-4182-6274-e053-6294a90a5e38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Calvin Scott & Co., Inc.
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17224-904-282023-03-15C16284748780-1ba0f9c33-533c-a910-e053-dadaa90a0b85These 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 capsules USP, for oral use CIV PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959
17224-904-282023-03-15C16284748780-1ba0f9c33-533c-a910-e053-dadaa90a0b85These 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 capsules USP, for oral use CIV PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959
17224-904-282021-01-29C16284748780-1ba0f9c33-533c-a910-e053-dadaa90a0b85These 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 capsules USP, for oral use CIV PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959
17224-904-282021-01-29C16284748780-1ba0f9c33-533c-a910-e053-dadaa90a0b85These 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 capsules USP, for oral use CIV PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17224-904-07Phentermine hydrochloride7 in 1 BOTTLETABLET72
17224-904-28Phentermine hydrochloride28 in 1 BOTTLETABLET282
17224-904-30Phentermine hydrochloride30 in 1 BOTTLETABLET302
17224-904-60Phentermine hydrochloride60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17224-904PHENTERMINE HYDROCHLORIDE TABLET [CALVIN SCOTT & CO., INC.]2Current NDC, Legacy NDC, 4 package rows20230316_3d1d4dde-1c7f-4a20-b8f8-897b1b284f80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN3d1d4dde-1c7f-4a20-b8f8-897b1b284f803
803353phentermine hydrochloride 37.5 MG Oral TabletSCD3d1d4dde-1c7f-4a20-b8f8-897b1b284f803
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY3d1d4dde-1c7f-4a20-b8f8-897b1b284f803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17224-904-07172240904077 TABLET in 1 BOTTLE (17224-904-07) 7 tablet2017-01-24NoNoCurrent
17224-904-141722409041414 TABLET in 1 BOTTLE (17224-904-14)14 tablet2017-01-240Current
17224-904-151722409041515 TABLET in 1 BOTTLE (17224-904-15)15 tablet2017-01-240Current
17224-904-281722409042828 TABLET in 1 BOTTLE (17224-904-28) 28 tablet2017-01-24NoNoCurrent
17224-904-301722409043030 TABLET in 1 BOTTLE (17224-904-30) 30 tablet2017-01-24NoNoCurrent
17224-904-421722409044242 TABLET in 1 BOTTLE (17224-904-42)42 tablet2017-01-240Current
17224-904-451722409044545 TABLET in 1 BOTTLE (17224-904-45)45 tablet2017-01-240Current
17224-904-561722409045656 TABLET in 1 BOTTLE (17224-904-56)56 tablet2017-01-240Current
17224-904-601722409046060 TABLET in 1 BOTTLE (17224-904-60) 60 tablet2017-01-24NoNoCurrent
17224-904-841722409048484 TABLET in 1 BOTTLE (17224-904-84)84 tablet2017-01-240Current
17224-904-901722409049090 TABLET in 1 BOTTLE (17224-904-90)90 tablet2017-01-240Current