Over-the-counter drug · ANDA

dg health 8 hr arthritis pain relief (Acetaminophen) NDC 55910-828

Acetaminophen 650 mg/1 · Tablet, Film coated, Extended release · Oral · Dolgencorp Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)55910-828Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55910-0828Add 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
55910-828-6255910082862559100828621 BOTTLE in 1 CARTON (55910-828-62) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Mar 20, 2020
55910-828-7855910082878559100828781 BOTTLE in 1 CARTON (55910-828-78) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Aug 19, 2019
55910-828-8355910082883559100828831 BOTTLE in 1 CARTON (55910-828-83) / 225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Mar 20, 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)
dg health 8 hr arthritis pain relief
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Dolgencorp IncNDC labeler code 55910
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075077
Marketing start
Listing expires
Identifiers
Product ID 55910-828_225d2cd8-e4bd-447f-b253-bcd6532c24f7SPL ID 225d2cd8-e4bd-447f-b253-bcd6532c24f7SPL set ID fc7838a7-fc6d-41b7-b8e4-97bee2bfa6d4RxCUI 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

N455910082862 followed by a unit qualifier and the quantity

Package 55910-0828-62. 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 55910-828

What is NDC 55910-828?
55910-828 is the product NDC for dg health 8 hr arthritis pain relief, Acetaminophen 650 mg/1 tablet, film coated, extended release, listed with the FDA by Dolgencorp Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
dg health 8 hr arthritis pain relief (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Dolgencorp Inc, NDC labeler code 55910. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for dg health 8 hr arthritis pain relief?
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 075077

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 075077
ProductStrengthForm · routeLabelerProduct NDC
DG Health 8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralDolgencorp Inc55910-749
Topcare 8 Hour Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralTopco Associates LLC36800-369
MedlineacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMedline Industries, LP53329-221
Good Sense Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-0044
equate 8hr arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALMART INC.79903-345
Care One arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmerican Sales Company41520-544
Acetaminophen 650mgacetaminophenAcetaminophen 650 mg/1TabletOralForreal Pharmaceuticals, LLC81877-850
topcare 8 hr arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralTopco Associates LLC36800-455
Leader 8HR Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0736
acetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralAmazon.com Services LLC72288-150
8 hr arthritis painacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-504
arthritis pain relieveracetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWalgreen Company0363-0544
Equate Menstrual Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralWALMART INC.79903-420
Midol Long Lasting ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralBayer HealthCare LLC.0280-8090
good sense pain relief arthritis painacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-2545
major acetaminophenacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralMajor Pharmaceuticals0904-6883
Members Mark Arthritis PainacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralSam's West Inc68196-611
good sense pain relief arthritis painacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-0544
arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralPublix Super Markets Inc56062-544
good sense pain relief arthritis painacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralASCLEMED USA INC.76420-590

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