FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
51224-101
11-digit product format
512240101
Labeler code
51224
Product ID
51224-101_bcfc205c-6118-4764-8734-efb2bd6f5308
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
TAGI Pharma, Inc.
Application
ANDA200272
Marketing category
ANDA
Marketing start
2011-03-08
Marketing end
2028-04-30
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
37.5 mg/1
Pharmacologic classes
Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui803353

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
51224-101-50Phentermine Hydrochloride100 in 1 BOTTLETABLET1009
51224-101-70Phentermine Hydrochloride1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51224-101-50EA - Each51224-1011d19eed8-4b2a-4113-9e8a-b5c9acd20bfd12012-07-24
51224-101-70EA - Each51224-1010e46bc13-1c88-4a05-9a49-ff961aa9fb2712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [TAGI PHARMA, INC.]5
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [TAGI PHARMA, INC.]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPHENTERMINE HYDROCHLORIDE TABLET [TAGI PHARMA, INC.]5
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48PHENTERMINE HYDROCHLORIDE TABLET [TAGI PHARMA, INC.]5
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE TABLET [TAGI PHARMA, INC.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [TAGI PHARMA, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51224-101PHENTERMINE HYDROCHLORIDE TABLET [TAGI PHARMA, INC.]8Current NDC, Legacy NDC, 2 package rows20190619_1993b181-f4f1-4451-92a0-7ed8f32598ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN328d6a39-34f4-4b74-a1bf-6ec6005b1322103
803353phentermine hydrochloride 37.5 MG Oral TabletSCD328d6a39-34f4-4b74-a1bf-6ec6005b1322103
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY328d6a39-34f4-4b74-a1bf-6ec6005b1322103
803353phentermine HCl 37.5 MG Oral TabletPSN707af68e-1630-4f86-87ba-1a643d2b4ef9102
803353phentermine hydrochloride 37.5 MG Oral TabletSCD707af68e-1630-4f86-87ba-1a643d2b4ef9102
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY707af68e-1630-4f86-87ba-1a643d2b4ef9102
803353phentermine HCl 37.5 MG Oral TabletPSNbd7393cb-2b72-4ecd-ba03-801b635b764710
803353phentermine hydrochloride 37.5 MG Oral TabletSCDbd7393cb-2b72-4ecd-ba03-801b635b764710
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYbd7393cb-2b72-4ecd-ba03-801b635b764710
803353phentermine HCl 37.5 MG Oral TabletPSN1993b181-f4f1-4451-92a0-7ed8f32598ba9
803353phentermine hydrochloride 37.5 MG Oral TabletSCD1993b181-f4f1-4451-92a0-7ed8f32598ba9
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY1993b181-f4f1-4451-92a0-7ed8f32598ba9
803353phentermine HCl 37.5 MG Oral TabletPSN8fe6b65d-ca61-40f0-90fc-255dfd0756112
803353phentermine hydrochloride 37.5 MG Oral TabletSCD8fe6b65d-ca61-40f0-90fc-255dfd0756112
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY8fe6b65d-ca61-40f0-90fc-255dfd0756112
803353phentermine HCl 37.5 MG Oral TabletPSN58263978-0b92-5c86-e053-2a91aa0aa5e11
803353phentermine HCl 37.5 MG Oral TabletPSN30b48126-45f3-21fa-e063-6294a90a968f1
803353phentermine HCl 37.5 MG Oral TabletPSNbfc81014-a516-411a-802d-fedfa038c4131
803353phentermine hydrochloride 37.5 MG Oral TabletSCD58263978-0b92-5c86-e053-2a91aa0aa5e11
803353phentermine hydrochloride 37.5 MG Oral TabletSCD30b48126-45f3-21fa-e063-6294a90a968f1
803353phentermine hydrochloride 37.5 MG Oral TabletSCDbfc81014-a516-411a-802d-fedfa038c4131
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY58263978-0b92-5c86-e053-2a91aa0aa5e11
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY30b48126-45f3-21fa-e063-6294a90a968f1
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYbfc81014-a516-411a-802d-fedfa038c4131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51224-101-5051224010150100 TABLET in 1 BOTTLE (51224-101-50) 100 tablet2011-03-082028-04-30NoNoCurrent
51224-101-70512240101701000 TABLET in 1 BOTTLE (51224-101-70) 1000 tablet2011-03-082028-04-30NoNoCurrent