FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
50090-0416
11-digit product format
500900416
Labeler code
50090
Product ID
50090-0416_247652ef-12b4-4ceb-937f-2d54b9661f3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040875
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0416-02023-02-07C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50090-0416-02023-02-07C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50090-0416-32023-02-07C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50090-0416-32023-02-07C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50090-0416-42023-02-07C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50090-0416-42023-02-07C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50090-0416-62023-02-07C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50090-0416-62023-02-07C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50090-0416-02023-01-30C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50090-0416-02023-01-30C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50090-0416-32023-01-30C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50090-0416-32023-01-30C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50090-0416-42023-01-30C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50090-0416-42023-01-30C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50090-0416-62023-01-30C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959
50090-0416-62023-01-30C16284748780-1f386c649-b95a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules, USP. Phentermine Hydrochloride Capsules, USP CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0416-0Phentermine Hydrochloride30 in 1 BOTTLECAPSULE3032
50090-0416-3Phentermine Hydrochloride14 in 1 BOTTLECAPSULE1432
50090-0416-4Phentermine Hydrochloride60 in 1 BOTTLECAPSULE6032
50090-0416-6Phentermine Hydrochloride28 in 1 BOTTLECAPSULE2832

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0416-0EA - Each50090-0416ecf17b4c-d18b-452e-8db3-6cedfb38a10f12021-08-05
50090-0416-3EA - Each50090-04168bc8e9b8-4f51-4d9a-9ffe-099cc9300f6c12023-08-08
50090-0416-6EA - Each50090-041631ef22dc-2741-41cd-93db-b6eaa5b0d4da12023-08-08

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 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 startMarketing endSampleExclude flagStatus
50090-0416-05009004160030 CAPSULE in 1 BOTTLE (50090-0416-0) 30 capsule2014-11-280000-00-00NoNoCurrent
50090-0416-35009004160314 CAPSULE in 1 BOTTLE (50090-0416-3) 14 capsule2014-11-280000-00-00NoNoCurrent
50090-0416-45009004160460 in 1 BOTTLEHistorical
50090-0416-65009004160628 CAPSULE in 1 BOTTLE (50090-0416-6) 28 capsule2014-11-280000-00-00NoNoCurrent