FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
66267-166
11-digit product format
662670166
Labeler code
66267
Product ID
66267-166_de470e33-3061-4178-e053-2995a90a6325
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
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
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
66267-166-072025-01-30C16284748780-12cef2736-5b65-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
66267-166-302025-01-30C16284748780-12cef2736-5b65-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
66267-166-452025-01-30C16284748780-12cef2736-5b65-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
66267-166-602025-01-30C16284748780-12cef2736-5b65-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-166-07Phentermine Hydrochloride7 in 1 BOTTLETABLET75
66267-166-30Phentermine Hydrochloride30 in 1 BOTTLETABLET305
66267-166-45Phentermine Hydrochloride45 in 1 BOTTLETABLET455
66267-166-60Phentermine Hydrochloride60 in 1 BOTTLETABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-166PHENTERMINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]5Legacy NDC, 4 package rows20220506_3eb22c54-9580-089b-e054-00144ff88e88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-166-07662670166077 TABLET in 1 BOTTLE (66267-166-07) 7 tablet2016-10-120000-00-00NoNoCurrent
66267-166-306626701663030 TABLET in 1 BOTTLE (66267-166-30) 30 tablet2016-10-120000-00-00NoNoCurrent
66267-166-456626701664545 TABLET in 1 BOTTLE (66267-166-45) 45 tablet2016-10-120000-00-00NoNoCurrent
66267-166-606626701666060 TABLET in 1 BOTTLE (66267-166-60) 60 tablet2016-10-120000-00-00NoNoCurrent