FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
10544-552
11-digit product format
105440552
Labeler code
10544
Product ID
10544-552_bb5ec995-bb58-47d2-a9f3-5cc29abe5d1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA040526
Marketing category
ANDA
Marketing start
2013-10-21
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
30 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
10544-552-302020-01-31C16284748780-19d75b9d0-d108-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
10544-552-452020-01-31C16284748780-19d75b9d0-d108-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
10544-552-602020-01-31C16284748780-19d75b9d0-d108-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
10544-552-30Phentermine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET303
10544-552-45Phentermine Hydrochloride45 in 1 BOTTLE, PLASTICTABLET453
10544-552-60Phentermine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET603

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
calcium phosphate, dibasic, dihydrateINACTIVE INGREDIENTO7TSZ97GEPPHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
crospovidoneINACTIVE INGREDIENT68401960MKPHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3
povidonesINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-552PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]3Legacy NDC, 3 package rows20150801_735d1c5f-ee7e-45c7-9f1a-458577498173.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-552-301054405523030 in 1 BOTTLE, PLASTICHistorical
10544-552-451054405524545 in 1 BOTTLE, PLASTICHistorical
10544-552-601054405526060 in 1 BOTTLE, PLASTICHistorical