Over-the-counter drug · ANDA

Acetaminophen NDC 63868-660

Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · CHAIN DRUG MARKETING ASSOCIATION INC

NDC codes

FDA NDC Directory
Product NDC (as listed)63868-660Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63868-0660Add 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
63868-660-0163868066001100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63868-660-01)Marketed from Aug 1, 2020
63868-660-50638680660501 BOTTLE, PLASTIC in 1 PACKAGE (63868-660-50) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTICMarketed from Aug 1, 2020

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)
Acetaminophen
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
CHAIN DRUG MARKETING ASSOCIATION INCNDC labeler code 63868
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
Marketing start
Marketing end
Identifiers
Product ID 63868-660_459b55dd-858e-ce9f-e063-6394a90a17d1SPL ID 459b55dd-858e-ce9f-e063-6394a90a17d1SPL set ID 2e30754a-42f7-4da2-944c-be61cee47b43RxCUI 1148399UNII 362O9ITL9DUPC 0635515954984

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

N463868066001 followed by a unit qualifier and the quantity

Package 63868-0660-01. 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: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63868-660

What is NDC 63868-660?
63868-660 is the product NDC for Acetaminophen, Acetaminophen 650 mg/1 tablet, extended release, listed with the FDA by CHAIN DRUG MARKETING ASSOCIATION INC. It has 2 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?
CHAIN DRUG MARKETING ASSOCIATION INC, NDC labeler code 63868. 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?
228 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 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
AcetaminophenAcetaminophen 500 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-413268788-4132-0168788-4132-0268788-4132-03+1 more
acetaminophenAcetaminophen 500 mg/1TabletOralUnit Dose Solutions, Inc.87441-00887441-0008-01
AcetaminophenAcetaminophen 160 mg/5mLSolutionOralAcetris Pharma Holdings, LLC52343-55552343-0555-12
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGranules India Limited62207-89262207-0892-4962207-0892-51

All 229 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
8 HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDr. Reddy's Laboratories Inc.75907-430
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMARC GLASSMAN, INC.68998-401
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 releaseOralDISCOUNT DRUG MART53943-200
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralVALU MERCHANDISERS COMPANY63941-300
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERIFOODS TRADING COMPANY61504-200
AcetaminophenAcetaminophen 650 mg/1TabletOralFAMILY DOLLAR55319-185
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralWINCO FOODS, LLC67091-401
AcetaminophenAcetaminophen 650 mg/1TabletOralMAJOR PHARMACEUTICALS0904-7314
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralVALU MERCHANDISERS COMPANY63941-401
AcetaminophenAcetaminophen 650 mg/1TabletOralWalgreens0363-0892
Acetaminophen Extended-ReleaseacetaminophenAcetaminophen 650 mg/1TabletOralMagno-Humphries, Inc.54257-573
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGrocery Outlet, Inc.85828-200
HebacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralHEB37808-120
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERISOURCE BERGEN46122-630
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGERI-CARE PHARMACEUTICAL CORP57896-268
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-679
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERISOURCE BERGEN46122-629
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-1340

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