acetaminophen and codeine phosphate

Product NDC
46672-561
11-digit product format
466720561
Labeler code
46672
Product ID
46672-561_b014eb77-95da-480c-e053-2a95a90ab006
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
LIQUID
Route
ORAL
Labeler
Mikart, LLC
Application
ANDA089450
Marketing category
ANDA
Marketing start
1992-10-27
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
120 mg/5mL; mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46672-561-16ML - Milliliter46672-56101bbc811-0cbd-4f89-bdc3-92c03b32bd0e12015-10-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46672-561-1646672056116473 mL in 1 BOTTLE (46672-561-16) 473 ml1992-10-270000-00-00NoNoCurrent