FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
33358-435
11-digit product format
333580435
Labeler code
33358
Product ID
33358-435_bafeb4a3-63d0-4e8f-a9fa-6c91e5b53925
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RxChange Co.
Application
ANDA040526
Marketing category
ANDA
Marketing start
2014-11-21
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
E
Listing certified through
2017-12-31
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
33358-435-302020-01-31C16284748780-19d75b9d1-1587-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33358-435-30Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33358-435-30EA - Each33358-435d5dea7aa-3d02-4974-a3f4-41bc19d37bcd12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]2
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]2
calcium phosphate, dibasic, dihydrateINACTIVE INGREDIENTO7TSZ97GEPPHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]2
crospovidoneINACTIVE INGREDIENT68401960MKPHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]2
povidonesINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]2
shellacINACTIVE INGREDIENT46N107B71OPHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33358-435PHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]2Legacy NDC, 1 package rows20141210_eed1670d-88a1-4edd-9de9-9eeb395970d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNeed1670d-88a1-4edd-9de9-9eeb395970d72
803353phentermine hydrochloride 37.5 MG Oral TabletSCDeed1670d-88a1-4edd-9de9-9eeb395970d72
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYeed1670d-88a1-4edd-9de9-9eeb395970d72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33358-435-303335804353030 in 1 BOTTLE, PLASTICHistorical