FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
61939-810
11-digit product format
619390810
Labeler code
61939
Product ID
61939-810_ddf2a781-8150-4452-97df-a41ff3caeff3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mikah Pharma, LLC
Application
ANDA040190
Marketing category
ANDA
Marketing start
2014-05-01
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
2019-12-31
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
61939-810-012020-01-31C16284748780-19d75b9d0-b272-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 CIV for oral use ]. Initial U.S. Approval: [1959]
61939-810-102020-01-31C16284748780-19d75b9d0-b272-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 CIV for oral use ]. Initial U.S. Approval: [1959]

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61939-810-01Phentermine Hydrochloride100 in 1 BOTTLETABLET1002
61939-810-10Phentermine Hydrochloride1000 in 1 BOTTLETABLET10002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]2
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61939-810PHENTERMINE HYDROCHLORIDE TABLET [MIKAH PHARMA, LLC]2Legacy NDC, 2 package rows20150227_ddf2a781-8150-4452-97df-a41ff3caeff3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNddf2a781-8150-4452-97df-a41ff3caeff32
803353phentermine hydrochloride 37.5 MG Oral TabletSCDddf2a781-8150-4452-97df-a41ff3caeff32
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYddf2a781-8150-4452-97df-a41ff3caeff32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61939-810-0161939081001100 in 1 BOTTLEHistorical
61939-810-10619390810101000 in 1 BOTTLEHistorical