Hydrocodone Bitartrate and Acetaminophen

Product NDC
43547-373
11-digit product format
435470373
Labeler code
43547
Product ID
43547-373_affd2152-d4da-4b04-98de-6cd0d0d375ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA040432
Marketing category
ANDA
Marketing start
2016-01-25
Marketing end
2020-11-02
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
8 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43547-373-102020-04-03C16284748780-19d75b9d1-0ebb-f424-e053-dadaa90a57ce3e4917e6-6995-4983-8c6f-823b3c1b52ad
43547-373-102020-01-31C16284748780-19d75b9d1-0ebb-f424-e053-dadaa90a57ce3e4917e6-6995-4983-8c6f-823b3c1b52ad

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-373-10EA - Each43547-3732d472a97-1b85-415d-af7b-a98f33bb132a12016-03-04