Hydrocodone Bitartrate and Acetaminophen

Product NDC
0254-2034
11-digit product format
002542034
Labeler code
0254
Product ID
0254-2034_2ec6751e-3479-4bef-a1fb-42b30c837186
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA202935
Marketing category
ANDA
Marketing start
2018-10-05
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0254-2034-01EA - Each0254-20344c4c8a35-5fcf-40f5-835c-0f02f5662e2b12019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0254-2034-0100254203401100 TABLET in 1 BOTTLE (0254-2034-01) 100 tablet2018-10-050000-00-00NoNoCurrent