FDA.reportPublic FDA data

PHENTERMINE HYDROCHLORIDE

Product NDC
42806-524
11-digit product format
428060524
Labeler code
42806
Product ID
42806-524_eb0dd945-2ebd-422f-9228-7460f93d7889
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA040228
Marketing category
ANDA
Marketing start
2015-04-15
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
37.5 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PHENTERMINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui803348

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
32c2b0bd-1f13-4890-99e0-dcd2ea16e1abProduct name220230717
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
ebeae3eb-385d-62da-8827-5ffa80b14e90Product name220170810
1d682039-1122-1cb7-f3f4-c0a028b98748Product name420170124
8ef9ca65-1a6c-7225-351d-36066d0f8e56Product name320161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-524-01PHENTERMINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE1005
42806-524-10PHENTERMINE HYDROCHLORIDE1000 in 1 BOTTLECAPSULE10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-524-01EA - Each42806-52433d2eb00-d67b-4c82-a8cb-8b715b434a2a12015-09-10
42806-524-10EA - Each42806-52417d2c95c-79b3-4db5-8d48-629ecc18d2ed12024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
SHELLACINACTIVE INGREDIENT46N107B71OPHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-524PHENTERMINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC]5Current NDC, Legacy NDC, 2 package rows20191123_06573bd8-67b4-4478-8325-aa6be25787cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803348phentermine HCl 37.5 MG Oral CapsulePSN06573bd8-67b4-4478-8325-aa6be25787cb5
803348phentermine hydrochloride 37.5 MG Oral CapsuleSCD06573bd8-67b4-4478-8325-aa6be25787cb5
803348phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral CapsuleSY06573bd8-67b4-4478-8325-aa6be25787cb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-524-0142806052401100 CAPSULE in 1 BOTTLE (42806-524-01) 100 capsule2015-04-150000-00-00NoNoCurrent
42806-524-10428060524101000 CAPSULE in 1 BOTTLE (42806-524-10) 1000 capsule2015-04-150000-00-00NoNoCurrent