FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
50436-3173
11-digit product format
504363173
Labeler code
50436
Product ID
50436-3173_e5039391-cac3-4e49-8f47-5eda84a4408e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA040526
Marketing category
ANDA
Marketing start
2003-10-23
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
38 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
2020-12-31
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
50436-3173-12021-01-29C16284748780-1ba0f9c33-4fb5-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
50436-3173-22021-01-29C16284748780-1ba0f9c33-4fb5-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
50436-3173-32021-01-29C16284748780-1ba0f9c33-4fb5-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
50436-3173-42021-01-29C16284748780-1ba0f9c33-4fb5-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3173-1Phentermine Hydrochloride7 in 1 BOTTLETABLET76
50436-3173-2Phentermine Hydrochloride14 in 1 BOTTLETABLET146
50436-3173-3Phentermine Hydrochloride28 in 1 BOTTLETABLET286
50436-3173-4Phentermine Hydrochloride21 in 1 BOTTLETABLET216

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-3173-1EA - Each50436-31735a06b659-a453-48eb-8d8f-9229f2cfdd7412015-10-02
50436-3173-2EA - Each50436-3173fa950219-c458-4be4-a3de-37fe63aabf5112015-10-02
50436-3173-3EA - Each50436-317388be5b5e-e4fe-461d-9255-8ada7bf2b28c12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
SHELLACINACTIVE INGREDIENT46N107B71OPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3173PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]6Legacy NDC, 4 package rows20190509_58462270-0b4d-455e-ae9d-d2e13d6cab3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN58462270-0b4d-455e-ae9d-d2e13d6cab3f6
803353phentermine hydrochloride 37.5 MG Oral TabletSCD58462270-0b4d-455e-ae9d-d2e13d6cab3f6
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY58462270-0b4d-455e-ae9d-d2e13d6cab3f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-3173-1504363173017 in 1 BOTTLEHistorical
50436-3173-25043631730214 in 1 BOTTLEHistorical
50436-3173-35043631730328 in 1 BOTTLEHistorical
50436-3173-45043631730421 in 1 BOTTLEHistorical