FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
68071-2888
11-digit product format
680712888
Labeler code
68071
Product ID
68071-2888_ee00aeb4-7caf-77d1-e053-2a95a90ab218
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phentermine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA205019
Marketing category
ANDA
Marketing start
2017-01-24
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
68071-2888-02025-01-30C16284748780-12cef2736-a7a8-d83d-e063-dadaa90ab31fThese 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
68071-2888-12025-01-30C16284748780-12cef2736-a7a8-d83d-e063-dadaa90ab31fThese 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
68071-2888-22025-01-30C16284748780-12cef2736-a7a8-d83d-e063-dadaa90ab31fThese 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
68071-2888-32025-01-30C16284748780-12cef2736-a7a8-d83d-e063-dadaa90ab31fThese 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
68071-2888-42025-01-30C16284748780-12cef2736-a7a8-d83d-e063-dadaa90ab31fThese 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
68071-2888-52025-01-30C16284748780-12cef2736-a7a8-d83d-e063-dadaa90ab31fThese 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
68071-2888-72025-01-30C16284748780-12cef2736-a7a8-d83d-e063-dadaa90ab31fThese 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
68071-2888-82025-01-30C16284748780-12cef2736-a7a8-d83d-e063-dadaa90ab31fThese 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
68071-2888-0Phentermine Hydrochloride84 in 1 BOTTLECAPSULE843
68071-2888-1Phentermine Hydrochloride21 in 1 BOTTLECAPSULE213
68071-2888-2Phentermine Hydrochloride112 in 1 BOTTLECAPSULE1123
68071-2888-3Phentermine Hydrochloride30 in 1 BOTTLECAPSULE303
68071-2888-4Phentermine Hydrochloride42 in 1 BOTTLECAPSULE423
68071-2888-5Phentermine Hydrochloride56 in 1 BOTTLECAPSULE563
68071-2888-7Phentermine Hydrochloride14 in 1 BOTTLECAPSULE143
68071-2888-8Phentermine Hydrochloride28 in 1 BOTTLECAPSULE283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2888PHENTERMINE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]3Legacy NDC, 8 package rows20231014_ee00aeb4-7cae-77d1-e053-2a95a90ab218.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSNee00aeb4-7cae-77d1-e053-2a95a90ab2183
900038phentermine hydrochloride 30 MG Oral CapsuleSCDee00aeb4-7cae-77d1-e053-2a95a90ab2183
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYee00aeb4-7cae-77d1-e053-2a95a90ab2183

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2888-06807128880084 in 1 BOTTLEHistorical
68071-2888-16807128880121 in 1 BOTTLEHistorical
68071-2888-268071288802112 in 1 BOTTLEHistorical
68071-2888-36807128880330 CAPSULE in 1 BOTTLE (68071-2888-3) 30 capsule2022-11-210000-00-00NoNoCurrent
68071-2888-46807128880442 in 1 BOTTLEHistorical
68071-2888-56807128880556 in 1 BOTTLEHistorical
68071-2888-76807128880714 in 1 BOTTLEHistorical
68071-2888-86807128880828 in 1 BOTTLEHistorical