Hydrocodone Bitartrate And Acetaminophen

Product NDC
53002-0156
11-digit product format
530020156
Labeler code
53002
Product ID
53002-0156_9821580e-03f2-4451-bba9-a6a48cc67448
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate And Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA040655
Marketing category
ANDA
Marketing start
2006-01-19
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-0156-15300201560110 TABLET in 1 BOTTLE (53002-0156-1) 10 tablet2018-10-010000-00-00NoNoCurrent
53002-0156-25300201560220 TABLET in 1 BOTTLE (53002-0156-2) 20 tablet2018-10-010000-00-00NoNoCurrent
53002-0156-35300201560330 TABLET in 1 BOTTLE (53002-0156-3) 30 tablet2018-10-010000-00-00NoNoCurrent
53002-0156-55300201560515 TABLET in 1 BOTTLE (53002-0156-5) 15 tablet2018-10-010000-00-00NoNoCurrent
53002-0156-9530020156095 TABLET in 1 BOTTLE (53002-0156-9) 5 tablet2018-10-010000-00-00NoNoCurrent