Over-the-counter drug · ANDA

DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mg (Acetaminophen) NDC 55959-179

Acetaminophen 650 mg/1 · Tablet · Oral · BENARD INDUSTRIES INC

NDC codes

FDA NDC Directory
Product NDC (as listed)55959-179Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55959-0179Add 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
55959-179-03559590179035595901790330 TABLET in 1 BOTTLE, PLASTIC (55959-179-03)Marketed from Jun 19, 2023

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)
DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mgSuffix: Extended-Release 650 mg
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet
Route
Oral
Labeler
BENARD INDUSTRIES INCNDC labeler code 55959
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211544
Marketing start
Listing expires
Identifiers
Product ID 55959-179_fe7f4c90-c5ec-d662-e053-6294a90a3961SPL ID fe7f4c90-c5ec-d662-e053-6294a90a3961SPL set ID eaa9d094-ece6-41fd-97d9-0fdb0a45afd7RxCUI 1148399UNII 362O9ITL9DUPC 0014457132047

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

N455959017903 followed by a unit qualifier and the quantity

Package 55959-0179-03. 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 55959-179

What is NDC 55959-179?
55959-179 is the product NDC for DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mg, Acetaminophen 650 mg/1 tablet, listed with the FDA by BENARD INDUSTRIES INC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mg (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
BENARD INDUSTRIES INC, NDC labeler code 55959. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for DOLO - NeuroBion Acetaminophen Max Extended-Release 650 mg?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in