Hydrocodone Bitartrate and Acetaminophen

Product NDC
50090-0843
11-digit product format
500900843
Labeler code
50090
Product ID
50090-0843_f0e73507-b20d-4e43-b4e1-40fe8f53c527
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040736
Marketing category
ANDA
Marketing start
2010-01-18
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0843-0EA - Each50090-084343f97107-99ae-40ee-b4a8-fa7f0aa9e55512021-08-05
50090-0843-7EA - Each50090-0843e6e82514-8111-41f3-b0a4-f209f69df2db12021-08-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0843-05009008430020 TABLET in 1 BOTTLE (50090-0843-0) 20 tablet2017-11-280000-00-00NoNoCurrent
50090-0843-25009008430260 TABLET in 1 BOTTLE (50090-0843-2) 60 tablet2017-11-280000-00-00NoNoCurrent
50090-0843-75009008430712 TABLET in 1 BOTTLE (50090-0843-7) 12 tablet2021-02-160000-00-00NoNoCurrent