Over-the-counter drug · ANDA

Topcare 8 Hour Pain Relief (acetaminophen) NDC 36800-369

Acetaminophen 650 mg/1 · Tablet, Film coated, Extended release · Oral · Topco Associates LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-369Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0369Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
36800-369-78368000369781 BOTTLE in 1 CARTON (36800-369-78) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Apr 5, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Topcare 8 Hour Pain Relief
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075077
Marketing start
Listing expires
Identifiers
Product ID 36800-369_c2db19bf-4ebf-4cd8-a6fd-892b50938f17SPL ID c2db19bf-4ebf-4cd8-a6fd-892b50938f17SPL set ID 38abe710-3d8a-41b0-b057-38c5dfd53322RxCUI 1148399UNII 362O9ITL9D

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N436800036978 followed by a unit qualifier and the quantity

Package 36800-0369-78. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 075077

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 075077
ProductStrengthForm · routeLabelerProduct NDC
Care One arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmerican Sales Company41520-544
basic care acetaminophenacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmazon.com Services LLC72288-634
Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralMeijer Distribution Inc41250-802
equate 8hr arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALMART INC.79903-345
Equate 8HR Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWal-Mart Stores Inc49035-741
Good Neighbor Pharmacy Menstrual Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmerisource Bergen46122-836
Acetaminophen 650mgacetaminophenAcetaminophen 650 mg/1TabletOralForreal Pharmaceuticals, LLC81877-850
Good Sense Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-0044
MedlineacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMedline Industries, LP53329-221
Midol Long Lasting ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralBayer HealthCare LLC.0280-8090
arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralMeijer Distribution Inc41250-966
topcare 8 hr arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralTopco Associates LLC36800-779
Equate Menstrual Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALMART INC.79903-420
8 hr arthritis painacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-504
DG Health 8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralDolgencorp Inc55910-749
major acetaminophenacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralMajor Pharmaceuticals0904-6883
arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralPublix Super Markets Inc56062-544
Pain Relief 8 HRacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralH E B37808-747
good sense pain relief arthritis painacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-2545
dg health 8 hr arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralDolgencorp Inc55910-828

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