Over-the-counter drug · ANDA
Direct Safety Ibuprofen (Ibuprofen) NDC 61245-085
Ibuprofen 200 mg/1 · Tablet, Coated · Oral · Conney Safety Products, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61245-085-13 | 61245008513 | 250 PACKET in 1 BOX (61245-085-13) / 2 TABLET, COATED in 1 PACKETMarketed from Feb 1, 2016 |
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)
- Direct Safety Ibuprofen
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Conney Safety Products, LLCNDC labeler code 61245
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075010
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 61245-085_3e5d63ea-c1b9-f7fc-e063-6394a90ae253SPL ID 3e5d63ea-c1b9-f7fc-e063-6394a90ae253SPL set ID 28d45743-d298-29db-e054-00144ff8d46cRxCUI 310965UNII WK2XYI10QM
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N461245008513followed by a unit qualifier and the quantityPackage 61245-0085-13. 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 associated with ■ headache ■ toothache ■ backache ■ menstrual cramps ■ common cold ■ muscular aches ■ minor arthritis pain Temporarily reduces fever.
Excerpt only. Read the full label for complete information.
About NDC 61245-085
- What is NDC 61245-085?
- 61245-085 is the product NDC for Direct Safety Ibuprofen (ibuprofen), Ibuprofen 200 mg/1 tablet, coated, listed with the FDA by Conney Safety Products, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Direct Safety Ibuprofen (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Conney Safety Products, LLC, NDC labeler code 61245. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Direct Safety Ibuprofen?
- 1 other product NDC are listed under this name. See all Direct Safety Ibuprofen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Direct Safety Ibuprofen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Direct Safety Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Conney Safety Products, LLC | 61245-084 | 61245-0084-13 |
Other NDCs under ANDA 075010
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 |
|---|---|---|---|---|
| Circle K Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Lil Drug Store Products, Inc | 66715-5539 |
| Dover Addaprinibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Unifirst First Aid Corporation | 47682-614 |
| Green Guard Ibupro reliefibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Unifirst First Aid Corporation | 47682-610 |
| Henry Schein Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Henry Schein Inc. | 0404-0017 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-0291 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-0292 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Rite Aid Corporation | 11822-0291 |
| Ibuprofenibuprofen 200mg | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 29485-9291 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Topco Associates, LLC | 36800-292 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | H E B | 37808-921 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | H E B | 37808-922 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-991 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Wal-Mart Stores Inc | 49035-912 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | L.N.K. International, Inc. | 50844-257 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | L.N.K. International, Inc. | 50844-291 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | L.N.K. International, Inc. | 50844-292 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-354 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Discount Drug Mart | 53943-291 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Discount Drug Mart | 53943-292 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Geritrex LLC | 54162-941 |
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