Over-the-counter drug · ANDA

Acetaminophen NDC 69848-015

Acetaminophen 650 mg/1 · Tablet, Film coated, Extended release · Oral · Granules USA, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)69848-015Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69848-0015Add 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
69848-015-106984800151069848001510100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69848-015-10)Marketed from Dec 31, 2019
69848-015-24698480015246984800152424 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69848-015-24)Marketed from Nov 30, 2022

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, Film coated, Extended release
Route
Oral
Labeler
Granules USA, Inc.NDC labeler code 69848
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
Marketing start
Listing expires
Identifiers
Product ID 69848-015_4690a42a-ee23-e19b-e063-6294a90a2d9fSPL ID 4690a42a-ee23-e19b-e063-6294a90a2d9fSPL set ID 96131c7b-bdff-0642-e053-2a95a90a4f32RxCUI 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

N469848001510 followed by a unit qualifier and the quantity

Package 69848-0015-10. 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: ■ 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 69848-015

What is NDC 69848-015?
69848-015 is the product NDC for Acetaminophen, Acetaminophen 650 mg/1 tablet, film coated, extended release, listed with the FDA by Granules USA, 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?
Granules USA, Inc., NDC labeler code 69848. 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?
227 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 228 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/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-660
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMARC GLASSMAN, INC.68998-401
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8624
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralSTRATEGIC SOURCING SERVICES LLC70677-1123
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERISOURCE BERGEN46122-629
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERISOURCE BERGEN46122-630
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralVALU MERCHANDISERS COMPANY63941-401
arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMeijer41250-658
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
Tylenol 8 Hr Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralKenvue Brands LLC50580-575
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralWINCO FOODS, LLC67091-401
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDISCOUNT DRUG MART53943-200
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-679
8HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralHARRIS TEETER72036-200
AcetaminophenAcetaminophen 650 mg/1TabletOralFAMILY DOLLAR55319-185
Acetaminophen Extended-ReleaseacetaminophenAcetaminophen 650 mg/1TabletOralMagno-Humphries, Inc.54257-573
AcetaminophenAcetaminophen 650 mg/1TabletOralWAL-MART STORES INC79903-137
AcetaminophenAcetaminophen 650 mg/1TabletOralMAJOR PHARMACEUTICALS0904-7314
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGERI-CARE PHARMACEUTICAL CORP57896-268

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