FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
17224-702
11-digit product format
172240702
Labeler code
17224
Product ID
17224-702_f95166c8-57c3-4c4a-9f88-dc7cbb86ce63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
CALVIN, SCOTT AND COMPANY, INCORPORATED
Application
ANDA040876
Marketing category
ANDA
Marketing start
2012-08-15
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
38 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
2020-12-31
Current FDA listing
Historical FDA.report record

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
17224-702-102021-01-29C16284748780-1ba0f9c33-3e5b-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 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
17224-702-10Phentermine Hydrochloride28 in 1 BOTTLETABLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17224-702PHENTERMINE HYDROCHLORIDE TABLET [CALVIN, SCOTT AND COMPANY, INCORPORATED]2Legacy NDC, 1 package rows20191120_fd9d346d-edae-477f-b2d4-278b9403bc89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNfd9d346d-edae-477f-b2d4-278b9403bc892
803353phentermine hydrochloride 37.5 MG Oral TabletSCDfd9d346d-edae-477f-b2d4-278b9403bc892
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYfd9d346d-edae-477f-b2d4-278b9403bc892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
17224-702-101722407021028 in 1 BOTTLEHistorical