Over-the-counter drug · ANDA
major acetaminophen (Acetaminophen) NDC 0904-6883
Acetaminophen 650 mg/1 · Tablet, Film coated, Extended release · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6883-65 | 0090468836500904688365 | 400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0904-6883-65)Marketed from Mar 4, 2019 |
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)
- major acetaminophen
- Generic name (nonproprietary)
- acetaminophen
- Active ingredients
- Acetaminophen — 650 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075077
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-6883_94ba0748-82d5-434b-8a2d-b4d7cc6b98acSPL ID 94ba0748-82d5-434b-8a2d-b4d7cc6b98acSPL set ID ca9e1dae-eefb-4653-952f-2fde09059693RxCUI 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
N400904688365followed by a unit qualifier and the quantityPackage 00904-6883-65. 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.
About NDC 0904-6883
- What is NDC 0904-6883?
- 0904-6883 is the product NDC for major acetaminophen (acetaminophen), Acetaminophen 650 mg/1 tablet, film coated, extended release, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- major acetaminophen (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 major acetaminophen?
- 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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| DG Health 8 Hour Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Dolgencorp Inc | 55910-749 |
| Topcare 8 Hour Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Topco Associates LLC | 36800-369 |
| Medlineacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Medline Industries, LP | 53329-221 |
| Good Sense Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | L. Perrigo Company | 0113-0044 |
| equate 8hr arthritis pain reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | WALMART INC. | 79903-345 |
| Care One arthritis pain reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | American Sales Company | 41520-544 |
| Acetaminophen 650mgacetaminophen | Acetaminophen 650 mg/1 | TabletOral | Forreal Pharmaceuticals, LLC | 81877-850 |
| topcare 8 hr arthritis pain reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Topco Associates LLC | 36800-455 |
| Leader 8HR Arthritis Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0736 |
| acetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Amazon.com Services LLC | 72288-150 |
| 8 hr arthritis painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-504 |
| arthritis pain relieveracetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Walgreen Company | 0363-0544 |
| Equate Menstrual Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | WALMART INC. | 79903-420 |
| dg health 8 hr arthritis pain reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Dolgencorp Inc | 55910-828 |
| Midol Long Lasting Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Bayer HealthCare LLC. | 0280-8090 |
| good sense pain relief arthritis painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-2545 |
| Members Mark Arthritis Painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Sam's West Inc | 68196-611 |
| good sense pain relief arthritis painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | L. Perrigo Company | 0113-0544 |
| arthritis pain reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Publix Super Markets Inc | 56062-544 |
| good sense pain relief arthritis painacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | ASCLEMED USA INC. | 76420-590 |
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