Over-the-counter drug · ANDA

Acetaminophen NDC 57896-268

Acetaminophen 650 mg/1 · Tablet, Extended release · Oral · GERI-CARE PHARMACEUTICAL CORP

NDC codes

FDA NDC Directory
Product NDC (as listed)57896-268Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57896-0268Add 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
57896-268-0157896026801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (57896-268-01)Marketed from Jul 1, 2019

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
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
Marketing start
Listing expires
Identifiers
Product ID 57896-268_1dee586b-62df-bc69-e063-6394a90aa329SPL ID 1dee586b-62df-bc69-e063-6394a90aa329SPL set ID 92c22593-daf9-20a8-e053-2a95a90a365dRxCUI 1148399UNII 362O9ITL9DUPC 0357896265014

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

N457896026801 followed by a unit qualifier and the quantity

Package 57896-0268-01. 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)

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
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralCHAIN DRUG CONSORTIUM68016-303
Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAAA Pharmaceutical, Inc.57344-200
8HR Muscle Aches and PainacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralAAA Pharmaceutical, Inc.57344-201
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGranules India Limited62207-188
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGranules India Limited62207-183
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralCVS PHARMACY iNC69842-297
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralRETAIL BUSINESS SERVICES,LLC.72476-185
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralRETAIL BUSINESS SERVICES,LLC.72476-186
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralCVS PHARMACY INC69842-322
AcetaminophenAcetaminophen 650 mg/1TabletOralWalgreens0363-0892
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGranules Pharmaceuticals Inc.70010-160
DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mgacetaminophenAcetaminophen 650 mg/1TabletOralBENARD INDUSTRIES INC55959-179
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralRITE AID11822-5019
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralGranules India Limited62207-892
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralRITE AID11822-5019
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8624
AcetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralRITE AID11822-5091
eight hour pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralUnited Natural Foods, Inc. dba UNFI41163-203
AcetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralBi-Mart37835-512
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralTOPCO ASSOCIATES LLC36800-632

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