Phentermine Hydrochloride

Product NDC
52959-432
11-digit product format
529590432
Labeler code
52959
Product ID
52959-432_39c69ed9-e45d-4099-b249-ddf710527e3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA087022
Marketing category
ANDA
Marketing start
2007-12-01
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
2018-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-432-07Phentermine Hydrochloride7 in 1 BOTTLECAPSULE71
52959-432-14Phentermine Hydrochloride14 in 1 BOTTLECAPSULE141
52959-432-30Phentermine Hydrochloride30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-432-07EA - Each52959-432792b2c20-8c34-4326-a356-9d792fb4192412012-07-24
52959-432-14EA - Each52959-43214d629a1-fd10-4e65-9c7f-3c6bc00b5a5412012-07-24
52959-432-30EA - Each52959-43237efea95-2576-410e-b57b-7e4c836d1d4712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
AlcoholINACTIVE INGREDIENT3K9958V90MPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
Aluminum OxideINACTIVE INGREDIENTLMI26O6933PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
Anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
D&C Yellow NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
FD&C Blue NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
FD&C Blue NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
FD&C Red NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
FD&C Red NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
GelatinINACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
Methyl AlcoholINACTIVE INGREDIENTY4S76JWI15PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
shellacINACTIVE INGREDIENT46N107B71OPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-432PHENTERMINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 3 package rows20111205_29bd88e3-215d-4c34-b22a-df159a2dd98d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN29bd88e3-215d-4c34-b22a-df159a2dd98d1
900038phentermine hydrochloride 30 MG Oral CapsuleSCD29bd88e3-215d-4c34-b22a-df159a2dd98d1
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY29bd88e3-215d-4c34-b22a-df159a2dd98d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-432-07529590432077 in 1 BOTTLEHistorical
52959-432-145295904321414 in 1 BOTTLEHistorical
52959-432-305295904323030 in 1 BOTTLEHistorical