Phentermine Hydrochloride

Product NDC
50436-6760
11-digit product format
504366760
Labeler code
50436
Product ID
50436-6760_53f446d9-0533-4379-a1f9-268c29a832cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA040526
Marketing category
ANDA
Marketing start
2013-08-12
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-6760-1Phentermine Hydrochloride7 in 1 BOTTLETABLET74
50436-6760-2Phentermine Hydrochloride14 in 1 BOTTLETABLET144
50436-6760-3Phentermine Hydrochloride21 in 1 BOTTLETABLET214
50436-6760-4Phentermine Hydrochloride28 in 1 BOTTLETABLET284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-6760-1EA - Each50436-6760429405d0-6e13-452f-914f-ca7ca83d276512017-09-11
50436-6760-2EA - Each50436-6760e1b93424-7461-462f-8506-a85933f3e12012017-09-11
50436-6760-4EA - Each50436-6760c10d07d2-a9d8-4d70-bf68-8b734f2c415d12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6760PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]4Legacy NDC, 4 package rows20171109_350cb4d3-bd67-4613-bde2-16208221d957.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-6760-1504366760017 in 1 BOTTLEHistorical
50436-6760-25043667600214 in 1 BOTTLEHistorical
50436-6760-35043667600321 in 1 BOTTLEHistorical
50436-6760-45043667600428 in 1 BOTTLEHistorical