FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
71335-0350
11-digit product format
713350350
Labeler code
71335
Product ID
71335-0350_abbf6752-a400-4afe-9550-b4eb0ba7687c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040526
Marketing category
ANDA
Marketing start
2013-08-12
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

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
71335-0350-0Phentermine Hydrochloride90 in 1 BOTTLETABLET9011
71335-0350-1Phentermine Hydrochloride7 in 1 BOTTLETABLET711
71335-0350-2Phentermine Hydrochloride14 in 1 BOTTLETABLET1411
71335-0350-3Phentermine Hydrochloride15 in 1 BOTTLETABLET1511
71335-0350-4Phentermine Hydrochloride28 in 1 BOTTLETABLET2811
71335-0350-5Phentermine Hydrochloride30 in 1 BOTTLETABLET3011
71335-0350-6Phentermine Hydrochloride45 in 1 BOTTLETABLET4511
71335-0350-7Phentermine Hydrochloride60 in 1 BOTTLETABLET6011
71335-0350-8Phentermine Hydrochloride42 in 1 BOTTLETABLET4211
71335-0350-9Phentermine Hydrochloride56 in 1 BOTTLETABLET5611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0350-0EA - Each71335-0350ba4c0897-4be8-4168-8db0-54b04beeca6412020-09-14
71335-0350-1EA - Each71335-0350b05614bb-af73-4f4d-b832-38a0d4f56c5c12018-05-09
71335-0350-2EA - Each71335-0350275e168a-69c7-4dc8-b56e-8f476e07230f12018-04-19
71335-0350-3EA - Each71335-0350babcffc4-2b81-4961-8ddd-a4210e1fcdf612018-05-09
71335-0350-4EA - Each71335-0350cb8f270f-6f92-4ba5-8fc7-1642dafa97ee12018-05-09
71335-0350-5EA - Each71335-03507a994341-202a-474f-a742-687452e7da6b12018-04-19
71335-0350-6EA - Each71335-0350632c61cf-9927-4fd2-ab9f-7f9ac1214b8f12018-04-19
71335-0350-7EA - Each71335-03503bbdd6c4-4a6a-42ad-8c65-a71fa154b0e912020-09-14
71335-0350-9EA - Each71335-0350d045dda0-53e3-4c84-ad6f-9e19d5beaf3112020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0350PHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 10 package rows20240822_53cad049-f1b4-42c0-9cc7-a1c2df75ac58.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0350-07133503500090 TABLET in 1 BOTTLE (71335-0350-0) 90 tablet2018-11-200000-00-00NoNoCurrent
71335-0350-1713350350017 TABLET in 1 BOTTLE (71335-0350-1) 7 tablet2018-04-100000-00-00NoNoCurrent
71335-0350-27133503500214 TABLET in 1 BOTTLE (71335-0350-2) 14 tablet2018-03-120000-00-00NoNoCurrent
71335-0350-37133503500315 TABLET in 1 BOTTLE (71335-0350-3) 15 tablet2018-03-200000-00-00NoNoCurrent
71335-0350-47133503500428 TABLET in 1 BOTTLE (71335-0350-4) 28 tablet2018-04-020000-00-00NoNoCurrent
71335-0350-57133503500530 TABLET in 1 BOTTLE (71335-0350-5) 30 tablet2018-03-270000-00-00NoNoCurrent
71335-0350-67133503500645 TABLET in 1 BOTTLE (71335-0350-6) 45 tablet2018-03-130000-00-00NoNoCurrent
71335-0350-77133503500760 TABLET in 1 BOTTLE (71335-0350-7) 60 tablet2018-04-060000-00-00NoNoCurrent
71335-0350-87133503500842 TABLET in 1 BOTTLE (71335-0350-8) 42 tablet2018-04-090000-00-00NoNoCurrent
71335-0350-97133503500956 TABLET in 1 BOTTLE (71335-0350-9) 56 tablet2018-03-260000-00-00NoNoCurrent