FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
71335-0161
11-digit product format
713350161
Labeler code
71335
Product ID
71335-0161_098e240a-c834-444a-a56c-933a6a102df5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200272
Marketing category
ANDA
Marketing start
2011-03-08
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
71335-0161-0Phentermine Hydrochloride90 in 1 BOTTLETABLET9010
71335-0161-1Phentermine Hydrochloride30 in 1 BOTTLETABLET3010
71335-0161-2Phentermine Hydrochloride15 in 1 BOTTLETABLET1510
71335-0161-3Phentermine Hydrochloride28 in 1 BOTTLETABLET2810
71335-0161-4Phentermine Hydrochloride7 in 1 BOTTLETABLET710
71335-0161-5Phentermine Hydrochloride14 in 1 BOTTLETABLET1410
71335-0161-6Phentermine Hydrochloride60 in 1 BOTTLETABLET6010
71335-0161-7Phentermine Hydrochloride45 in 1 BOTTLETABLET4510
71335-0161-8Phentermine Hydrochloride2 in 1 BOTTLETABLET210
71335-0161-9Phentermine Hydrochloride21 in 1 BOTTLETABLET2110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0161-0EA - Each71335-016155567e73-664a-45b6-a2c2-bf84ae0c9a3412018-03-08
71335-0161-1EA - Each71335-0161af0a9579-97f5-4ad2-8ffb-e09bdd0e663812018-03-08
71335-0161-2EA - Each71335-01617e901ea6-48a2-4953-b9f1-d221f754d24a12018-03-08
71335-0161-3EA - Each71335-0161f7a37ef9-608f-4e41-ad3f-3b60ce18304e12018-03-08
71335-0161-4EA - Each71335-01612177a1e6-772a-47a6-93ea-46410878abc912018-03-08
71335-0161-5EA - Each71335-0161497b2b76-bc00-4e0b-999c-0443f0b9220e12018-03-08
71335-0161-6EA - Each71335-0161914321dc-5b2e-433e-8e7c-68efecca164212018-03-08
71335-0161-7EA - Each71335-016137debf84-fa45-44ea-875c-8ad855e417d912018-03-08
71335-0161-8EA - Each71335-01613a426481-adbe-432e-b079-fb5003cdcc0e12018-03-08
71335-0161-9EA - Each71335-01616880c822-9f27-45e5-a0f2-d3627090278612018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0161PHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 10 package rows20240809_bd7393cb-2b72-4ecd-ba03-801b635b7647.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0161-07133501610090 TABLET in 1 BOTTLE (71335-0161-0) 90 tablet2011-03-080000-00-00NoNoCurrent
71335-0161-17133501610130 TABLET in 1 BOTTLE (71335-0161-1) 30 tablet2011-03-080000-00-00NoNoCurrent
71335-0161-27133501610215 TABLET in 1 BOTTLE (71335-0161-2) 15 tablet2011-03-080000-00-00NoNoCurrent
71335-0161-37133501610328 TABLET in 1 BOTTLE (71335-0161-3) 28 tablet2011-03-080000-00-00NoNoCurrent
71335-0161-4713350161047 TABLET in 1 BOTTLE (71335-0161-4) 7 tablet2011-03-080000-00-00NoNoCurrent
71335-0161-57133501610514 TABLET in 1 BOTTLE (71335-0161-5) 14 tablet2011-03-080000-00-00NoNoCurrent
71335-0161-67133501610660 TABLET in 1 BOTTLE (71335-0161-6) 60 tablet2011-03-080000-00-00NoNoCurrent
71335-0161-77133501610745 TABLET in 1 BOTTLE (71335-0161-7) 45 tablet2011-03-080000-00-00NoNoCurrent
71335-0161-8713350161082 TABLET in 1 BOTTLE (71335-0161-8) 2 tablet2011-03-080000-00-00NoNoCurrent
71335-0161-97133501610921 TABLET in 1 BOTTLE (71335-0161-9) 21 tablet2011-03-080000-00-00NoNoCurrent