Phentermine Hydrochloride

Product NDC
50090-0119
11-digit product format
500900119
Labeler code
50090
Product ID
50090-0119_247652ef-12b4-4ceb-937f-2d54b9661f3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040886
Marketing category
ANDA
Marketing start
2012-08-07
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
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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui900038, 968766

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0119-0Phentermine Hydrochloride30 in 1 BOTTLECAPSULE3032
50090-0119-2Phentermine Hydrochloride14 in 1 BOTTLECAPSULE1432
50090-0119-3Phentermine Hydrochloride7 in 1 BOTTLECAPSULE732
50090-0119-4Phentermine Hydrochloride28 in 1 BOTTLECAPSULE2832

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0119-0EA - Each50090-01197d9cefaa-9a6e-453a-b0fe-c795b8da78db12025-05-14
50090-0119-3EA - Each50090-0119a8de7d8d-73d3-495d-9cc1-da297a20f75512025-05-14
50090-0119-4EA - Each50090-01195a842240-e37a-456e-9b28-3c3ac14f2e4c12025-05-14

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0119PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]28Current NDC, 4 package rows20250313_5234cabd-6b3e-404d-a0cd-256ee5fcc8f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN5234cabd-6b3e-404d-a0cd-256ee5fcc8f132
900038phentermine HCl 30 MG Oral CapsulePSN5234cabd-6b3e-404d-a0cd-256ee5fcc8f132
968766phentermine hydrochloride 15 MG Oral CapsuleSCD5234cabd-6b3e-404d-a0cd-256ee5fcc8f132
900038phentermine hydrochloride 30 MG Oral CapsuleSCD5234cabd-6b3e-404d-a0cd-256ee5fcc8f132
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY5234cabd-6b3e-404d-a0cd-256ee5fcc8f132
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY5234cabd-6b3e-404d-a0cd-256ee5fcc8f132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-0119-05009001190030 CAPSULE in 1 BOTTLE (50090-0119-0) 30 capsule2014-11-28NoNoCurrent
50090-0119-25009001190214 in 1 BOTTLEHistorical
50090-0119-3500900119037 CAPSULE in 1 BOTTLE (50090-0119-3) 7 capsule2014-11-28NoNoCurrent
50090-0119-45009001190428 CAPSULE in 1 BOTTLE (50090-0119-4) 28 capsule2014-11-28NoNoCurrent