FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
0527-1445
11-digit product format
005271445
Labeler code
0527
Product ID
0527-1445_71a5941a-3831-4042-989d-1c47e1b65bab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
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
2023-12-31
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
0527-1445-012024-01-30C16284748780-11030e365-3d7f-111a-e063-dadaa90a10e2adf965bd-86cc-4313-9253-c151585f3f94
0527-1445-102024-01-30C16284748780-11030e365-3d7f-111a-e063-dadaa90a10e2adf965bd-86cc-4313-9253-c151585f3f94
0527-1445-302024-01-30C16284748780-11030e365-3d7f-111a-e063-dadaa90a10e2adf965bd-86cc-4313-9253-c151585f3f94

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1445-01EA - Each0527-14453eec4ee5-af6d-4384-872f-5e45dcc835e012012-07-24
0527-1445-10EA - Each0527-1445618434e9-d736-40c6-a9e4-91aeab056a4512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]3
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE TABLET [DIRECT RX]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNef061dd2-1b35-49bf-beda-8c9fe02e5f9f10
803353phentermine hydrochloride 37.5 MG Oral TabletSCDef061dd2-1b35-49bf-beda-8c9fe02e5f9f10
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYef061dd2-1b35-49bf-beda-8c9fe02e5f9f10
803353phentermine HCl 37.5 MG Oral TabletPSN501437ae-f4a2-4e54-b033-eccc53a060378
803353phentermine hydrochloride 37.5 MG Oral TabletSCD501437ae-f4a2-4e54-b033-eccc53a060378
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY501437ae-f4a2-4e54-b033-eccc53a060378
900038phentermine HCl 30 MG Oral CapsulePSN8a947cf6-c578-0405-e053-2995a90a3e0e6
803353phentermine HCl 37.5 MG Oral TabletPSN8a947cf6-c578-0405-e053-2995a90a3e0e6
900038phentermine hydrochloride 30 MG Oral CapsuleSCD8a947cf6-c578-0405-e053-2995a90a3e0e6
803353phentermine hydrochloride 37.5 MG Oral TabletSCD8a947cf6-c578-0405-e053-2995a90a3e0e6
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY8a947cf6-c578-0405-e053-2995a90a3e0e6
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY8a947cf6-c578-0405-e053-2995a90a3e0e6
803353phentermine HCl 37.5 MG Oral TabletPSNd0663bfb-810c-44f9-acc1-3166fe6eedde2
803353phentermine hydrochloride 37.5 MG Oral TabletSCDd0663bfb-810c-44f9-acc1-3166fe6eedde2
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYd0663bfb-810c-44f9-acc1-3166fe6eedde2
803353phentermine HCl 37.5 MG Oral TabletPSN8739f879-9af6-4fd6-b8b0-12dc4fee20a01
803353phentermine hydrochloride 37.5 MG Oral TabletSCD8739f879-9af6-4fd6-b8b0-12dc4fee20a01
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY8739f879-9af6-4fd6-b8b0-12dc4fee20a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1445-0100527144501100 TABLET in 1 BOTTLE (0527-1445-01) 100 tablet2005-04-150000-00-00NoNoCurrent
0527-1445-10005271445101000 TABLET in 1 BOTTLE (0527-1445-10) 1000 tablet2005-04-150000-00-00NoNoCurrent
0527-1445-300052714453030 TABLET in 1 BOTTLE (0527-1445-30) 30 tablet2005-04-150000-00-00NoNoCurrent