Modafinil

Product NDC
68071-2844
11-digit product format
680712844
Labeler code
68071
Product ID
68071-2844_ea3e248d-a47f-74d7-e053-2a95a90add6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Modafinil
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078963
Marketing category
ANDA
Marketing start
2022-02-28
Marketing end
0000-00-00
Substance
MODAFINIL
Active strength
200 mg/1
Pharmacologic classes
Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [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
91b7dea8-da1b-abb1-9750-2e680cd894b6Product name220171005

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2844-3Modafinil1 in 1 CARTONTABLET11
68071-2844-3Modafinil3 in 1 BOTTLE, PLASTICTABLET31

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205324modafinil 200 MG Oral TabletPSNea3decc2-a34e-13d6-e053-2995a90a7b5d1
205324modafinil 200 MG Oral TabletSCDea3decc2-a34e-13d6-e053-2995a90a7b5d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2844-3680712844031 BOTTLE, PLASTIC in 1 CARTON (68071-2844-3) > 3 TABLET in 1 BOTTLE, PLASTIC2022-10-040000-00-00NoNoCurrent