FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
71335-1933
11-digit product format
713351933
Labeler code
71335
Product ID
71335-1933_042f7f75-1da1-4377-a119-7ffd7624a7a9
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
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 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
71335-1933-1Phentermine Hydrochloride30 in 1 BOTTLECAPSULE30103
71335-1933-2Phentermine Hydrochloride7 in 1 BOTTLECAPSULE7103
71335-1933-3Phentermine Hydrochloride14 in 1 BOTTLECAPSULE14103
71335-1933-4Phentermine Hydrochloride28 in 1 BOTTLECAPSULE28103
71335-1933-5Phentermine Hydrochloride90 in 1 BOTTLECAPSULE90103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1933PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 5 package rows20250215_81751ece-8ccb-4aec-91ad-037c1d9fea53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN81751ece-8ccb-4aec-91ad-037c1d9fea53103
900038phentermine hydrochloride 30 MG Oral CapsuleSCD81751ece-8ccb-4aec-91ad-037c1d9fea53103
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY81751ece-8ccb-4aec-91ad-037c1d9fea53103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1933-17133519330130 CAPSULE in 1 BOTTLE (71335-1933-1) 30 capsule2022-10-130000-00-00NoNoCurrent
71335-1933-2713351933027 CAPSULE in 1 BOTTLE (71335-1933-2) 7 capsule2022-10-130000-00-00NoNoCurrent
71335-1933-37133519330314 CAPSULE in 1 BOTTLE (71335-1933-3) 14 capsule2022-10-130000-00-00NoNoCurrent
71335-1933-47133519330428 CAPSULE in 1 BOTTLE (71335-1933-4) 28 capsule2022-10-130000-00-00NoNoCurrent
71335-1933-57133519330590 CAPSULE in 1 BOTTLE (71335-1933-5) 90 capsule2021-08-110000-00-00NoNoCurrent