Phentermine Hydrochloride

Product NDC
10544-099
11-digit product format
105440099
Labeler code
10544
Product ID
10544-099_1314a031-867b-718d-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA040886
Marketing category
ANDA
Marketing start
2013-03-18
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
15 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
10544-099-212020-01-31C16284748780-19d75b9d0-2d88-f424-e053-dadaa90a57ceUnknown Title

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-099-21Phentermine Hydrochloride21 in 1 BOTTLECAPSULE214

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-099PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]4Legacy NDC, 1 package rows20150407_5866bdc2-1bf1-48d4-bbd2-b50d8276344c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN5866bdc2-1bf1-48d4-bbd2-b50d8276344c4
900038phentermine HCl 30 MG Oral CapsulePSN5866bdc2-1bf1-48d4-bbd2-b50d8276344c4
968766phentermine hydrochloride 15 MG Oral CapsuleSCD5866bdc2-1bf1-48d4-bbd2-b50d8276344c4
900038phentermine hydrochloride 30 MG Oral CapsuleSCD5866bdc2-1bf1-48d4-bbd2-b50d8276344c4
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY5866bdc2-1bf1-48d4-bbd2-b50d8276344c4
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY5866bdc2-1bf1-48d4-bbd2-b50d8276344c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-099-211054400992121 in 1 BOTTLEHistorical