NDC 50580-309

Tylenol 8HR

Acetaminophen

Tylenol 8HR is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Acetaminophen.

• Product ID: 50580-309_169f82b9-f989-4f24-aed0-09578d027a7f
• NDC: 50580-309
• Product Type: Human Otc Drug
• Proprietary Name: Tylenol 8HR
• Generic Name: Acetaminophen
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-01-18
• Marketing Category: NDA / NDA
• Application Number: NDA019872
• Labeler Name: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• Substance Name: ACETAMINOPHEN
• Active Ingredient Strength: 650 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50580-309-01

1 BOTTLE in 1 CARTON (50580-309-01) > 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

• Marketing Start Date: 2016-01-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-309-01 [50580030901]

Tylenol 8HR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA019872
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-01-18

NDC 50580-309-02 [50580030902]

Tylenol 8HR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA019872
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-01-18

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	650 mg/1

OpenFDA Data

• SPL SET ID: 5d7d1300-bcb8-466a-880b-310b360ee132
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • 362O9ITL9D
• RxNorm Concept Unique ID - RxCUI:
  • 1148399
  • 1243440
• UPC Code:
  • 0300450297211

NDC Crossover Matching brand name "Tylenol 8HR" or generic name "Acetaminophen"

NDC	Brand Name	Generic Name
50580-309	Tylenol 8HR	Tylenol 8HR
0121-0657	Acetaminophen	Acetaminophen
0113-7000	Basic Care acetaminophen	Acetaminophen
0113-7484	basic care acetaminophen	Acetaminophen
0113-7544	Basic Care Acetaminophen	Acetaminophen
0113-7130	basic care childrens pain and fever	Acetaminophen
0113-0020	good sense childrens pain and fever	Acetaminophen
0113-0212	Good Sense Childrens Pain and Fever	Acetaminophen
0113-0608	good sense childrens pain and fever	Acetaminophen
0113-0998	Good Sense Childrens Pain and Fever	Acetaminophen
0113-0161	Good Sense pain and fever	Acetaminophen
0113-0397	Good Sense Pain and Fever	acetaminophen
0113-0590	Good Sense Pain and Fever	acetaminophen
0113-0946	good sense pain and fever	Acetaminophen
0113-8959	Good Sense Pain and Fever	Acetaminophen
0113-0025	Good Sense Pain Relief	Acetaminophen
0113-0044	Good Sense Pain Relief	Acetaminophen
0113-0187	good sense pain relief	Acetaminophen
0113-0217	good sense pain relief	Acetaminophen
0113-0227	Good Sense Pain Relief	Acetaminophen
0113-0403	good sense pain relief	Acetaminophen
0113-0484	Good Sense Pain Relief	Acetaminophen
0113-0518	good sense pain relief	Acetaminophen
0113-0544	good sense pain relief	Acetaminophen
0113-1889	good sense pain relief	acetaminophen
0113-1975	Good Sense Pain Relief	Acetaminophen
0031-9301	Robitussin Direct Sore Throat Pain	acetaminophen