FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
51655-875
11-digit product format
516550875
Labeler code
51655
Product ID
51655-875_486f8bbf-f409-00ff-e063-6294a90a34c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA040526
Marketing category
ANDA
Marketing start
2014-05-15
Marketing end
2026-06-30
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-875-242026-01-13C16284748780-19d75b9d0-7414-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS. PHENTERMINE HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1959
51655-875-252026-01-13C16284748780-19d75b9d0-7414-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS. PHENTERMINE HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1959
51655-875-902026-01-13C16284748780-19d75b9d0-7414-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS. PHENTERMINE HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1959
51655-875-242020-01-31C16284748780-19d75b9d0-7414-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS. PHENTERMINE HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1959
51655-875-252020-01-31C16284748780-19d75b9d0-7414-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS. PHENTERMINE HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1959
51655-875-902020-01-31C16284748780-19d75b9d0-7414-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS. PHENTERMINE HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-875-24Phentermine Hydrochloride30 in 1 BOTTLE, DISPENSINGTABLET304
51655-875-25Phentermine Hydrochloride60 in 1 BOTTLE, DISPENSINGTABLET604
51655-875-90Phentermine Hydrochloride45 in 1 BOTTLE, DISPENSINGTABLET454

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]2
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-875PHENTERMINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 3 package rows20140821_d1d74574-9ebc-45fc-86e9-8cbd59acacd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNd1d74574-9ebc-45fc-86e9-8cbd59acacd44
803353phentermine hydrochloride 37.5 MG Oral TabletSCDd1d74574-9ebc-45fc-86e9-8cbd59acacd44
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYd1d74574-9ebc-45fc-86e9-8cbd59acacd44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-875-245165508752430 TABLET in 1 BOTTLE, DISPENSING (51655-875-24) 30 tablet2014-05-152026-06-30NoNoHistorical
51655-875-255165508752560 TABLET in 1 BOTTLE, DISPENSING (51655-875-25) 60 tablet2014-05-152026-06-30NoNoHistorical
51655-875-905165508759045 TABLET in 1 BOTTLE, DISPENSING (51655-875-90) 45 tablet2014-05-152026-06-30NoNoHistorical