FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
71335-3017
11-digit product format
713353017
Labeler code
71335
Product ID
71335-3017_b1f1a5dd-7f53-4ac4-aee3-0a64203c3db3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phentermine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205019
Marketing category
ANDA
Marketing start
2017-01-24
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K2I505OTV
Rxcui900038

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
71335-3017-1Phentermine Hydrochloride30 in 1 BOTTLECAPSULE301
71335-3017-2Phentermine Hydrochloride42 in 1 BOTTLECAPSULE421
71335-3017-3Phentermine Hydrochloride14 in 1 BOTTLECAPSULE141
71335-3017-4Phentermine Hydrochloride20 in 1 BOTTLECAPSULE201
71335-3017-5Phentermine Hydrochloride28 in 1 BOTTLECAPSULE281
71335-3017-6Phentermine Hydrochloride60 in 1 BOTTLECAPSULE601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSNfa5de92d-a5bf-4ae1-8e13-ad827aeebea31
900038phentermine hydrochloride 30 MG Oral CapsuleSCDfa5de92d-a5bf-4ae1-8e13-ad827aeebea31
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYfa5de92d-a5bf-4ae1-8e13-ad827aeebea31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3017-17133530170130 CAPSULE in 1 BOTTLE (71335-3017-1) 30 capsule2026-02-04NoNoHistorical
71335-3017-27133530170242 CAPSULE in 1 BOTTLE (71335-3017-2) 42 capsule2026-02-04NoNoHistorical
71335-3017-37133530170314 CAPSULE in 1 BOTTLE (71335-3017-3) 14 capsule2026-02-04NoNoHistorical
71335-3017-47133530170420 CAPSULE in 1 BOTTLE (71335-3017-4) 20 capsule2026-02-04NoNoHistorical
71335-3017-57133530170528 CAPSULE in 1 BOTTLE (71335-3017-5) 28 capsule2026-02-04NoNoHistorical
71335-3017-67133530170660 CAPSULE in 1 BOTTLE (71335-3017-6) 60 capsule2026-02-04NoNoHistorical