Over-the-counter drug · ANDA

Acetaminophen NDC 0904-7314

Acetaminophen 650 mg/1 · Tablet · Oral · MAJOR PHARMACEUTICALS

NDC codes

FDA NDC Directory
Product NDC (as listed)0904-7314Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-7314Add 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
0904-7314-2700904731427400 TABLET in 1 BOTTLE (0904-7314-27)Marketed from Mar 3, 2023
0904-7314-6000904731460100 TABLET in 1 BOTTLE (0904-7314-60)Marketed from Mar 3, 2023

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
Route
Oral
Labeler
MAJOR PHARMACEUTICALSNDC labeler code 0904
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
Marketing start
Listing expires
Identifiers
Product ID 0904-7314_465309f8-55b3-9cbf-e063-6294a90a8ca8SPL ID 465309f8-55b3-9cbf-e063-6294a90a8ca8SPL set ID efd0a432-abbb-1f88-e053-2995a90a8ce5RxCUI 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

N400904731427 followed by a unit qualifier and the quantity

Package 00904-7314-27. 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 0904-7314

What is NDC 0904-7314?
0904-7314 is the product NDC for Acetaminophen, Acetaminophen 650 mg/1 tablet, listed with the FDA by MAJOR PHARMACEUTICALS. 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?
MAJOR PHARMACEUTICALS, NDC labeler code 0904. 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 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERISOURCE BERGEN46122-629
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralVALU MERCHANDISERS COMPANY63941-300
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMARC GLASSMAN, INC.68998-401
8 Hour Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-083
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAMERISOURCE BERGEN46122-630
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION INC63868-679
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralVALU MERCHANDISERS COMPANY63941-401
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralSTRATEGIC SOURCING SERVICES LLC70677-1123
8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-082
8 HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralDr. Reddy's Laboratories Inc.75907-430
8HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralHARRIS TEETER72036-200
8HR Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralFSA STORE INC.81522-200
8HR Muscle Aches and PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAAA Pharmaceutical, Inc.57344-201
8HR Muscle Aches and PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralFSA STORE INC.81522-201
AcetaminophenAcetaminophen 650 mg/1TabletOralWalgreens0363-0892
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALGREENS0363-9992
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALGREENS CO.0363-9993
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8624
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralRITE AID11822-5019
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralRITE AID11822-5091

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