Tramadol Hydrochloride and Acetaminophen

Product NDC
50090-3248
11-digit product format
500903248
Labeler code
50090
Product ID
50090-3248_569a29d9-8fa0-4c7f-9614-f1f09f801291
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207152
Marketing category
ANDA
Marketing start
2017-03-22
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Active strength
38 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3248-1EA - Each50090-324800d9825d-8759-46fa-a3b0-d4f02522b2a512019-05-02