Over-the-counter drug · ANDA

Acetaminophen NDC 0363-9992

Acetaminophen 650 mg/1 · Tablet, Film coated, Extended release · Oral · WALGREENS

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-9992Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-9992Add 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
0363-9992-100036399921000363999210100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-9992-10)Marketed from Sep 28, 2019
0363-9992-200036399922000363999220200 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-9992-20)Marketed from Sep 28, 2019
0363-9992-24003639992240036399922424 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-9992-24)Marketed from Sep 28, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Acetaminophen
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
WALGREENSNDC labeler code 0363
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
Marketing start
Listing expires
Identifiers
Product ID 0363-9992_4652e567-f625-3c68-e063-6394a90a6610SPL ID 4652e567-f625-3c68-e063-6394a90a6610SPL set ID 8f8d43d1-8e73-483e-e053-2a95a90ac99bRxCUI 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

N400363999210 followed by a unit qualifier and the quantity

Package 00363-9992-10. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Uses ■ temporarily relieves minor aches and pains due to: ■ muscular aches ■ backache ■ minor pain of arthritis ■ toothache ■ premenstrual and menstrual cramps ■ headache ■ the common cold ■ temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0363-9992

What is NDC 0363-9992?
0363-9992 is the product NDC for Acetaminophen, Acetaminophen 650 mg/1 tablet, film coated, extended release, listed with the FDA by WALGREENS. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Acetaminophen.
What is the active ingredient?
Acetaminophen.
Who is the labeler?
WALGREENS, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acetaminophen?
234 other product NDCs are listed under this name. See all Acetaminophen NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Acetaminophen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
acetaminophenAcetaminophen 500 mg/1TabletOralREMEDYREPACK INC.70518-478770518-4787-00
AcetaminophenAcetaminophen 325 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-478270518-4782-0070518-4782-01
AcetaminophenAcetaminophen 500 mg/1TabletOralREMEDYREPACK INC.70518-478370518-4783-00
AcetaminophenAcetaminophen 500 mg/1TabletOralAmazon.com Services LLC72288-44072288-0440-09
acetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmazon.com Services LLC72288-15072288-0150-79
AcetaminophenAcetaminophen 10 mg/mLInjection, SolutionIntravenousSomerset Therapeutics, LLC70069-87170069-0871-10
AcetaminophenAcetaminophen 500 mg/1TabletOralWalgreens0363-981000363-9810-1000363-9810-2500363-9810-50+1 more
AcetaminophenAcetaminophen 500 mg/1TabletOralPUBLIX SUPERMARKETS, INC41415-17541415-0175-0541415-0175-10
AcetaminophenAcetaminophen 500 mg/1TabletOralFamily Dollar, Inc.55319-75155319-0751-24
AcetaminophenAcetaminophen 500 mg/1TabletOralMeijer Distribution Inc79481-078079481-0780-0179481-0780-0279481-0780-04

All 235 Acetaminophen NDCs

Other NDCs under ANDA 211544

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

FDA NDC Directory listings under ANDA 211544
ProductStrengthForm · routeLabelerProduct NDC
AcetaminophenAcetaminophen 650 mg/1TabletOralWAL-MART STORES INC79903-137
Tylenol 8 Hr Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralKenvue Brands LLC50580-575
Tylenol 8 Hr Muscle Aches And PainacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralKenvue Brands LLC50580-576
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERIFOODS TRADING COMPANY61504-200
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralWINCO FOODS, LLC67091-401
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-660
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMARC GLASSMAN, INC.68998-401
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDISCOUNT DRUG MART53943-200
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-679
AcetaminophenAcetaminophen 650 mg/1TabletOralFAMILY DOLLAR55319-185
8HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralHARRIS TEETER72036-200
Acetaminophen Extended-ReleaseacetaminophenAcetaminophen 650 mg/1TabletOralMagno-Humphries, Inc.54257-573
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralRITE AID11822-5019
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralRITE AID11822-5019
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGERI-CARE PHARMACEUTICAL CORP57896-268
eight hour pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralUnited Natural Foods, Inc. dba UNFI41163-203
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralRITE AID11822-5091
AcetaminophenAcetaminophen 650 mg/1TabletOralMEIJER DISTRIBUTION INC79481-0183
AcetaminophenAcetaminophen 650 mg/1TabletOralMEIJER, INC.79481-0184
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGrocery Outlet, Inc.85828-200

Showing 20 of 39.

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