FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
71335-1591
11-digit product format
713351591
Labeler code
71335
Product ID
71335-1591_960278a8-2bb7-4231-afcd-f9563c604f10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202248
Marketing category
ANDA
Marketing start
2012-02-17
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
71335-1591-0Phentermine Hydrochloride24 in 1 BOTTLECAPSULE243
71335-1591-1Phentermine Hydrochloride30 in 1 BOTTLECAPSULE303
71335-1591-2Phentermine Hydrochloride7 in 1 BOTTLECAPSULE73
71335-1591-3Phentermine Hydrochloride14 in 1 BOTTLECAPSULE143
71335-1591-4Phentermine Hydrochloride56 in 1 BOTTLECAPSULE563
71335-1591-5Phentermine Hydrochloride60 in 1 BOTTLECAPSULE603
71335-1591-6Phentermine Hydrochloride2 in 1 BOTTLECAPSULE23
71335-1591-7Phentermine Hydrochloride21 in 1 BOTTLECAPSULE213
71335-1591-8Phentermine Hydrochloride28 in 1 BOTTLECAPSULE283
71335-1591-9Phentermine Hydrochloride42 in 1 BOTTLECAPSULE423

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1591PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 10 package rows20240823_039db899-0f3c-4634-95ad-7fa915fe7043.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN039db899-0f3c-4634-95ad-7fa915fe70433
900038phentermine hydrochloride 30 MG Oral CapsuleSCD039db899-0f3c-4634-95ad-7fa915fe70433
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY039db899-0f3c-4634-95ad-7fa915fe70433

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1591-07133515910024 CAPSULE in 1 BOTTLE (71335-1591-0) 24 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-17133515910130 CAPSULE in 1 BOTTLE (71335-1591-1) 30 capsule2020-05-080000-00-00NoNoCurrent
71335-1591-2713351591027 CAPSULE in 1 BOTTLE (71335-1591-2) 7 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-37133515910314 CAPSULE in 1 BOTTLE (71335-1591-3) 14 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-47133515910456 CAPSULE in 1 BOTTLE (71335-1591-4) 56 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-57133515910560 CAPSULE in 1 BOTTLE (71335-1591-5) 60 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-6713351591062 CAPSULE in 1 BOTTLE (71335-1591-6) 2 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-77133515910721 CAPSULE in 1 BOTTLE (71335-1591-7) 21 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-87133515910828 CAPSULE in 1 BOTTLE (71335-1591-8) 28 capsule2024-08-120000-00-00NoNoCurrent
71335-1591-97133515910942 CAPSULE in 1 BOTTLE (71335-1591-9) 42 capsule2024-08-120000-00-00NoNoCurrent