Hydrocodone Bitartrate And Acetaminophen

Product NDC
63739-704
11-digit product format
637390704
Labeler code
63739
Product ID
63739-704_3df7fcaf-aa4a-4829-ac63-90bd463ca23a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate And Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-704-102020-07-22C16284748780-1ab0e2407-2914-f274-e053-dbdaa90a6471107033c5-679b-487c-aa33-49e8c35c6419

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-704-10EA - Each63739-7040709db36-1a52-49d3-9fa6-194bee043a3012014-10-03