Phentermine Hydrochloride

Product NDC
50090-4216
11-digit product format
500904216
Labeler code
50090
Product ID
50090-4216_3e0a21ce-eb1a-40fd-8c2d-411e88aef849
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203068
Marketing category
ANDA
Marketing start
2014-08-06
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
38 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
2023-12-31
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
50090-4216-0Phentermine Hydrochloride30 in 1 BOTTLETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4216-0EA - Each50090-4216a606d844-438b-425c-9b1a-b45c6f25303712022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4216PHENTERMINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]5Legacy NDC, 1 package rows20220729_1d1d27e7-7ef9-4c74-809a-695111208430.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN1d1d27e7-7ef9-4c74-809a-6951112084305
803353phentermine hydrochloride 37.5 MG Oral TabletSCD1d1d27e7-7ef9-4c74-809a-6951112084305
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY1d1d27e7-7ef9-4c74-809a-6951112084305

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4216-05009042160030 TABLET in 1 BOTTLE (50090-4216-0) 30 tablet2019-03-250000-00-00NoNoCurrent