FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
84053-025
11-digit product format
840530025
Labeler code
84053
Product ID
84053-025_3a9b5a93-de52-2dd1-e063-6394a90a311d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Martek Pharmacal Co.
Application
ANDA040876
Marketing category
ANDA
Marketing start
2024-02-01
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride
Listing expiration
2026-12-31

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
84053-025-07Phentermine Hydrochloride7 in 1 BOTTLETABLET75
84053-025-14Phentermine Hydrochloride14 in 1 BOTTLETABLET145
84053-025-28Phentermine Hydrochloride28 in 1 BOTTLETABLET285
84053-025-56Phentermine Hydrochloride56 in 1 BOTTLETABLET565

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84053-025PHENTERMINE HYDROCHLORIDE TABLET [MARTEK PHARMACAL CO.]2Current NDC, 4 package rows20240209_c4e9ec2e-4660-4442-93d7-c05a16e137b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSNc4e9ec2e-4660-4442-93d7-c05a16e137b55
803353phentermine hydrochloride 37.5 MG Oral TabletSCDc4e9ec2e-4660-4442-93d7-c05a16e137b55
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYc4e9ec2e-4660-4442-93d7-c05a16e137b55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84053-025-07840530025077 TABLET in 1 BOTTLE (84053-025-07) 7 tablet2024-02-01NoNoCurrent
84053-025-148405300251414 TABLET in 1 BOTTLE (84053-025-14) 14 tablet2024-02-01NoNoCurrent
84053-025-288405300252828 TABLET in 1 BOTTLE (84053-025-28) 28 tablet2024-02-01NoNoCurrent
84053-025-568405300255656 TABLET in 1 BOTTLE (84053-025-56) 56 tablet2024-02-01NoNoCurrent