Over-the-counter drug · ANDA
topcare 8 hr arthritis pain relief (Acetaminophen) NDC 36800-455
Acetaminophen 650 mg/1 · Tablet, Film coated, Extended release · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-455-83 | 3680004558336800045583 | 1 BOTTLE in 1 CARTON (36800-455-83) / 225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Apr 16, 2024 |
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)
- topcare 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
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075077
- Marketing start
- Listing expires
- Identifiers
- Product ID 36800-455_6be40153-a08e-4a37-8416-75167ab0efa6SPL ID 6be40153-a08e-4a37-8416-75167ab0efa6SPL set ID a82f8818-1c22-46d0-b05f-698d2395ac48RxCUI 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
N436800045583followed by a unit qualifier and the quantityPackage 36800-0455-83. 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 36800-455
- What is NDC 36800-455?
- 36800-455 is the product NDC for topcare 8 hr arthritis pain relief, Acetaminophen 650 mg/1 tablet, film coated, extended release, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- topcare 8 hr arthritis pain relief (Acetaminophen).
- What is the active ingredient?
- Acetaminophen.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for topcare 8 hr arthritis pain relief?
- 1 other product NDC are listed under this name. See all topcare 8 hr arthritis pain relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other topcare 8 hr arthritis pain relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| topcare 8 hr arthritis pain reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Topco Associates LLC | 36800-779 | 36800-0779-47 |
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 |
| 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 |
| major acetaminophenacetaminophen | Acetaminophen 650 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6883 |
| 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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