Over-the-counter drug · ANDA

arthritis pain relief (Acetaminophen) NDC 56062-544

Acetaminophen 650 mg/1 · Tablet, Film coated, Extended release · Oral · Publix Super Markets Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)56062-544Labeler and product segments. Claims need a package NDC.
Product NDC at billing width56062-0544Add 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
56062-544-6256062054462560620544621 BOTTLE in 1 CARTON (56062-544-62) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Nov 26, 2007
56062-544-7856062054478560620544781 BOTTLE in 1 CARTON (56062-544-78) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Nov 28, 2007

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)
arthritis pain relief
Generic name (nonproprietary)
acetaminophen
Active ingredients
Acetaminophen — 650 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Publix Super Markets IncNDC labeler code 56062
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075077
Marketing start
Listing expires
Identifiers
Product ID 56062-544_072ddb1b-cc26-41f9-be4b-993f99be6c02SPL ID 072ddb1b-cc26-41f9-be4b-993f99be6c02SPL set ID af407852-5476-421d-a80a-d726c24b6391RxCUI 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

N456062054462 followed by a unit qualifier and the quantity

Package 56062-0544-62. 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 56062-544

What is NDC 56062-544?
56062-544 is the product NDC for arthritis pain relief (acetaminophen), Acetaminophen 650 mg/1 tablet, film coated, extended release, listed with the FDA by Publix Super Markets Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
arthritis pain relief (Acetaminophen).
What is the active ingredient?
Acetaminophen.
Who is the labeler?
Publix Super Markets Inc, NDC labeler code 56062. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for arthritis pain relief?
7 other product NDCs are listed under this name. See all arthritis pain relief 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 arthritis pain relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Arthritis Pain Reliefdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-51751316-0517-00
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralKROGER COMPANY41226-69941226-0699-0141226-0699-2641226-0699-42
Arthritis Pain Reliefcamphor, capsaicin, methyl salicylateCamphor (Synthetic) 128.04 mg/1 + 2 more ingredientsPatchTopicalYUNNAN BAIYAO GROUP CO., LTD.61658-00261658-0002-01
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralWINCO FOODS, LLC67091-40167091-0401-02
Arthritis Pain ReliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralTOPCO ASSOCIATES LLC36800-63236800-0632-0136800-0632-0236800-0632-03+1 more
arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Extended releaseOralMeijer41250-65841250-0658-03
arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralMeijer Distribution Inc41250-96641250-0966-47

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
dg health 8 hr arthritis pain reliefacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralDolgencorp Inc55910-828
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
good sense pain relief arthritis painacetaminophenAcetaminophen 650 mg/1Tablet, Film coated, Extended releaseOralASCLEMED USA INC.76420-590

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