Phentermine Hydrochloride

Product NDC
10544-593
11-digit product format
105440593
Labeler code
10544
Product ID
10544-593_4035c0a2-7dc1-4bc3-9446-e05614d0c38b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA087022
Marketing category
ANDA
Marketing start
2010-03-04
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
10544-593-282019-10-21C16284748780-1956f9ecf-cca5-621f-e053-dbdaa90a74adPHENTERMINE HYDROCHLORIDE CAPSULES, USP CIV
10544-593-302019-10-21C16284748780-1956f9ecf-cca5-621f-e053-dbdaa90a74adPHENTERMINE HYDROCHLORIDE CAPSULES, USP CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-593-28Phentermine Hydrochloride28 in 1 BOTTLECAPSULE281
10544-593-30Phentermine Hydrochloride30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-593-28EA - Each10544-593679fa14b-3ea5-4820-b32c-062c5fab2d2912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
AlcoholINACTIVE INGREDIENT3K9958V90MPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
Anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
D&C Red NO. 28INACTIVE INGREDIENT767IP0Y5NHPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
D&C Yellow NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C Blue NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C Blue NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C Red NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
GelatinINACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
Methyl AlcoholINACTIVE INGREDIENTY4S76JWI15PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
shellacINACTIVE INGREDIENT46N107B71OPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-593PHENTERMINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20100824_56f0bb46-57d5-4556-a00c-4f6820e4e6ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN56f0bb46-57d5-4556-a00c-4f6820e4e6ce1
900038phentermine hydrochloride 30 MG Oral CapsuleSCD56f0bb46-57d5-4556-a00c-4f6820e4e6ce1
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY56f0bb46-57d5-4556-a00c-4f6820e4e6ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-593-281054405932828 in 1 BOTTLEHistorical
10544-593-301054405933030 in 1 BOTTLEHistorical