NDC 61919-860

ACETAMINOPHEN ER

Acetaminophen

ACETAMINOPHEN ER is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Directrx. The primary component is Acetaminophen.

Product ID61919-860_876fef38-0ec9-e076-e053-2a95a90a3565
NDC61919-860
Product TypeHuman Otc Drug
Proprietary NameACETAMINOPHEN ER
Generic NameAcetaminophen
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-04-26
Marketing CategoryANDA / ANDA
Application NumberANDA076200
Labeler NameDirectRX
Substance NameACETAMINOPHEN
Active Ingredient Strength650 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-860-71

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-860-71)
Marketing Start Date2019-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-860-71 [61919086071]

ACETAMINOPHEN ER TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA076200
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-04-26

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/1

NDC Crossover Matching brand name "ACETAMINOPHEN ER" or generic name "Acetaminophen"

NDCBrand NameGeneric Name
61919-860ACETAMINOPHEN ERACETAMINOPHEN ER
0121-0657AcetaminophenAcetaminophen
0113-7000Basic Care acetaminophenAcetaminophen
0113-7484basic care acetaminophenAcetaminophen
0113-7544Basic Care AcetaminophenAcetaminophen
0113-7130basic care childrens pain and feverAcetaminophen
0113-0020good sense childrens pain and feverAcetaminophen
0113-0212Good Sense Childrens Pain and FeverAcetaminophen
0113-0608good sense childrens pain and feverAcetaminophen
0113-0998Good Sense Childrens Pain and FeverAcetaminophen
0113-0161Good Sense pain and feverAcetaminophen
0113-0397Good Sense Pain and Feveracetaminophen
0113-0590Good Sense Pain and Feveracetaminophen
0113-0946good sense pain and feverAcetaminophen
0113-8959Good Sense Pain and FeverAcetaminophen
0113-0025Good Sense Pain ReliefAcetaminophen
0113-0044Good Sense Pain ReliefAcetaminophen
0113-0187good sense pain reliefAcetaminophen
0113-0217good sense pain reliefAcetaminophen
0113-0227Good Sense Pain ReliefAcetaminophen
0113-0403good sense pain reliefAcetaminophen
0113-0484Good Sense Pain ReliefAcetaminophen
0113-0518good sense pain reliefAcetaminophen
0113-0544good sense pain reliefAcetaminophen
0113-1889good sense pain reliefacetaminophen
0113-1975Good Sense Pain ReliefAcetaminophen
0031-9301Robitussin Direct Sore Throat Painacetaminophen

Trademark Results [ACETAMINOPHEN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACETAMINOPHEN
ACETAMINOPHEN
85615223 not registered Dead/Abandoned
General Merchandise importers and Expoters
2012-05-03

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