Phentermine Hydrochloride

Product NDC
63187-515
11-digit product format
631870515
Labeler code
63187
Product ID
63187-515_8c15a2ef-5730-43fc-82c5-840b8afe8422
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040555
Marketing category
ANDA
Marketing start
2005-04-15
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-515PHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]4Legacy NDC20200428_c291fc1b-976d-44e0-b50f-691c6f0a936e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-515-07631870515077 TABLET in 1 BOTTLE (63187-515-07) 7 tablet2018-12-010000-00-00NoNoCurrent
63187-515-156318705151515 TABLET in 1 BOTTLE (63187-515-15) 15 tablet2018-12-010000-00-00NoNoCurrent
63187-515-306318705153030 TABLET in 1 BOTTLE (63187-515-30) 30 tablet2018-12-010000-00-00NoNoCurrent
63187-515-606318705156060 TABLET in 1 BOTTLE (63187-515-60) 60 tablet2018-12-010000-00-00NoNoCurrent
63187-515-906318705159090 TABLET in 1 BOTTLE (63187-515-90) 90 tablet2018-12-010000-00-00NoNoCurrent