Phentermine Hydrochloride

Product NDC
0527-1438
11-digit product format
005271438
Labeler code
0527
Product ID
0527-1438_13517af4-9eee-422d-ae02-2a0f09101d74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA091359
Marketing category
ANDA
Marketing start
2010-07-19
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0527-1438-012024-01-30C16284748780-11030e364-fd13-111a-e063-dadaa90a10e24af88a94-22c3-4da1-b8d9-a73ef68a51b6
0527-1438-102024-01-30C16284748780-11030e364-fd13-111a-e063-dadaa90a10e24af88a94-22c3-4da1-b8d9-a73ef68a51b6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN376084de-d360-5732-e054-00144ff88e881
900038phentermine hydrochloride 30 MG Oral CapsuleSCD376084de-d360-5732-e054-00144ff88e881
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY376084de-d360-5732-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1438-0100527143801100 CAPSULE in 1 BOTTLE (0527-1438-01) 100 capsule2010-07-190000-00-00NoNoCurrent
0527-1438-10005271438101000 CAPSULE in 1 BOTTLE (0527-1438-10) 1000 capsule2010-07-190000-00-00NoNoCurrent