TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product NDC
70518-2784
11-digit product format
705182784
Labeler code
70518
Product ID
70518-2784_d70d9b2c-4f2e-7492-e053-2995a90ae012
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA201952
Marketing category
ANDA
Marketing start
2020-06-12
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2784-02022-02-02C16284748780-1d6a99b39-6228-a426-e053-dadaa90af4c2b0b5dca9-695e-48fb-89e9-83132e14a799
70518-2784-02022-01-28C16284748780-1d6a99b39-6228-a426-e053-dadaa90af4c2b0b5dca9-695e-48fb-89e9-83132e14a799

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2784-07051827840030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2784-0) 2020-06-120000-00-00NoNoCurrent