FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
50436-3176
11-digit product format
504363176
Labeler code
50436
Product ID
50436-3176_18723264-f933-49a2-ae5e-cfb576ec15bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA087022
Marketing category
ANDA
Marketing start
2007-12-01
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-3176-12021-01-29C16284748780-1ba0f9c33-2cb8-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use phentermine hydrochloride capsules, USP safely and effectively. See full prescribing information for phentermine hydrochloride capsules, USP. PHENTERMINE Hydrochloride Capsules, USP for oral use CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3176-1Phentermine Hydrochloride21 in 1 BOTTLECAPSULE214

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3176PHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]4Legacy NDC, 1 package rows20170926_a56c3aa5-ca6f-4c14-ab07-fbb3f8be060c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSNa56c3aa5-ca6f-4c14-ab07-fbb3f8be060c4
900038phentermine hydrochloride 30 MG Oral CapsuleSCDa56c3aa5-ca6f-4c14-ab07-fbb3f8be060c4
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYa56c3aa5-ca6f-4c14-ab07-fbb3f8be060c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-3176-15043631760121 in 1 BOTTLEHistorical