FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
68071-2640
11-digit product format
680712640
Labeler code
68071
Product ID
68071-2640_ea3be7c7-2d90-0ace-e053-2a95a90a47df
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
15 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
68071-2640-32025-01-30C16284748780-12cef2736-663e-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
68071-2640-62025-01-30C16284748780-12cef2736-663e-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
68071-2640-82025-01-30C16284748780-12cef2736-663e-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
68071-2640-3Phentermine Hydrochloride30 in 1 BOTTLECAPSULE304
68071-2640-6Phentermine Hydrochloride60 in 1 BOTTLECAPSULE604
68071-2640-8Phentermine Hydrochloride28 in 1 BOTTLECAPSULE284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2640PHENTERMINE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]4Legacy NDC, 3 package rows20230412_d7984a71-d70a-3e88-e053-2a95a90a97a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSNd7984a71-d70a-3e88-e053-2a95a90a97a24
968766phentermine hydrochloride 15 MG Oral CapsuleSCDd7984a71-d70a-3e88-e053-2a95a90a97a24
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYd7984a71-d70a-3e88-e053-2a95a90a97a24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2640-36807126400330 CAPSULE in 1 BOTTLE (68071-2640-3) 30 capsule2022-02-090000-00-00NoNoCurrent
68071-2640-66807126400660 CAPSULE in 1 BOTTLE (68071-2640-6) 60 capsule2022-02-090000-00-00NoNoCurrent
68071-2640-86807126400828 in 1 BOTTLEHistorical