FDA.reportPublic FDA data

Phentermine hydrochloride

Product NDC
71335-3107
11-digit product format
713353107
Labeler code
71335
Product ID
71335-3107_1a792fd4-4ba0-458d-90d1-b5dde6a5934a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phentermine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205008
Marketing category
ANDA
Marketing start
2017-01-24
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine hydrochloride
Listing expiration
2027-12-31

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
71335-3107-0Phentermine hydrochloride90 in 1 BOTTLETABLET901
71335-3107-1Phentermine hydrochloride30 in 1 BOTTLETABLET301
71335-3107-2Phentermine hydrochloride15 in 1 BOTTLETABLET151
71335-3107-3Phentermine hydrochloride28 in 1 BOTTLETABLET281
71335-3107-4Phentermine hydrochloride7 in 1 BOTTLETABLET71
71335-3107-5Phentermine hydrochloride14 in 1 BOTTLETABLET141
71335-3107-6Phentermine hydrochloride60 in 1 BOTTLETABLET601
71335-3107-7Phentermine hydrochloride45 in 1 BOTTLETABLET451
71335-3107-8Phentermine hydrochloride2 in 1 BOTTLETABLET21
71335-3107-9Phentermine hydrochloride21 in 1 BOTTLETABLET211

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN9155edf8-ea1d-458f-b2a7-e0303fd83cc01
803353phentermine hydrochloride 37.5 MG Oral TabletSCD9155edf8-ea1d-458f-b2a7-e0303fd83cc01
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY9155edf8-ea1d-458f-b2a7-e0303fd83cc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3107-07133531070090 TABLET in 1 BOTTLE (71335-3107-0) 90 tablet2026-03-16NoNoHistorical
71335-3107-17133531070130 TABLET in 1 BOTTLE (71335-3107-1) 30 tablet2026-03-16NoNoHistorical
71335-3107-27133531070215 TABLET in 1 BOTTLE (71335-3107-2) 15 tablet2026-03-16NoNoHistorical
71335-3107-37133531070328 TABLET in 1 BOTTLE (71335-3107-3) 28 tablet2026-03-16NoNoHistorical
71335-3107-4713353107047 TABLET in 1 BOTTLE (71335-3107-4) 7 tablet2026-03-16NoNoHistorical
71335-3107-57133531070514 TABLET in 1 BOTTLE (71335-3107-5) 14 tablet2026-03-16NoNoHistorical
71335-3107-67133531070660 TABLET in 1 BOTTLE (71335-3107-6) 60 tablet2026-03-16NoNoHistorical
71335-3107-77133531070745 TABLET in 1 BOTTLE (71335-3107-7) 45 tablet2026-03-16NoNoHistorical
71335-3107-8713353107082 TABLET in 1 BOTTLE (71335-3107-8) 2 tablet2026-03-16NoNoHistorical
71335-3107-97133531070921 TABLET in 1 BOTTLE (71335-3107-9) 21 tablet2026-03-16NoNoHistorical