Phentermine Hydrochloride

Product NDC
69677-293
11-digit product format
696770293
Labeler code
69677
Product ID
69677-293_58263978-0b93-5c86-e053-2a91aa0aa5e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mas Management Group, Inc.
Application
ANDA200272
Marketing category
ANDA
Marketing start
2011-03-08
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
E
Listing certified through
2018-12-31
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
69677-293-072020-01-31C16284748780-19d75b9d0-08b9-f424-e053-dadaa90a57ceThese 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
69677-293-142020-01-31C16284748780-19d75b9d0-08b9-f424-e053-dadaa90a57ceThese 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
69677-293-302020-01-31C16284748780-19d75b9d0-08b9-f424-e053-dadaa90a57ceThese 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
69677-293-602020-01-31C16284748780-19d75b9d0-08b9-f424-e053-dadaa90a57ceThese 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
69677-293-902020-01-31C16284748780-19d75b9d0-08b9-f424-e053-dadaa90a57ceThese 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
69677-293-07Phentermine Hydrochloride7 in 1 BOTTLETABLET71
69677-293-14Phentermine Hydrochloride14 in 1 BOTTLETABLET141
69677-293-30Phentermine Hydrochloride30 in 1 BOTTLETABLET301
69677-293-60Phentermine Hydrochloride60 in 1 BOTTLETABLET601
69677-293-90Phentermine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69677-293PHENTERMINE HYDROCHLORIDE TABLET [MAS MANAGEMENT GROUP, INC.]1Legacy NDC, 5 package rows20170929_58263978-0b92-5c86-e053-2a91aa0aa5e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN58263978-0b92-5c86-e053-2a91aa0aa5e11
803353phentermine hydrochloride 37.5 MG Oral TabletSCD58263978-0b92-5c86-e053-2a91aa0aa5e11
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY58263978-0b92-5c86-e053-2a91aa0aa5e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69677-293-07696770293077 in 1 BOTTLEHistorical
69677-293-146967702931414 in 1 BOTTLEHistorical
69677-293-306967702933030 in 1 BOTTLEHistorical
69677-293-606967702936060 in 1 BOTTLEHistorical
69677-293-906967702939090 in 1 BOTTLEHistorical