NDC 0485-0057

ED APAP

Acetaminophen

ED APAP is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Edwards Pharmaceuticals, Inc.. The primary component is Acetaminophen.

• Product ID: 0485-0057_9d2f2fbf-0dd3-414f-9747-23dd7e7a7408
• NDC: 0485-0057
• Product Type: Human Otc Drug
• Proprietary Name: ED APAP
• Generic Name: Acetaminophen
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2012-03-07
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Labeler Name: EDWARDS PHARMACEUTICALS, INC.
• Substance Name: ACETAMINOPHEN
• Active Ingredient Strength: 160 mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0485-0057-08

236 mL in 1 BOTTLE, PLASTIC (0485-0057-08)

• Marketing Start Date: 2012-03-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0485-0057-08 [00485005708]

ED APAP LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-03-07
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-04-08

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

OpenFDA Data

• SPL SET ID: f76d5fff-ebea-40f9-aad3-4064a0c863f0
• Manufacturer:
  • EDWARDS PHARMACEUTICALS, INC.
• UNII:
  • 362O9ITL9D
• RxNorm Concept Unique ID - RxCUI:
  • 307675
• UPC Code:
  • 0300485005782

NDC Crossover Matching brand name "ED APAP" or generic name "Acetaminophen"

NDC	Brand Name	Generic Name
0485-0057	ED APAP	ED APAP
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