Over-the-counter drug · ANDA
Direct Safety Ibuprofen (Ibuprofen) NDC 61245-084
Ibuprofen 200 mg/1 · Tablet, Coated · Oral · Conney Safety Products, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61245-084-13 | 61245008413 | 250 PACKET in 1 BOX (61245-084-13) / 2 TABLET, COATED in 1 PACKETMarketed from Nov 17, 2014 |
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 079174
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 61245-084_3e5d726a-c5b3-989b-e063-6394a90aeb7dSPL ID 3e5d726a-c5b3-989b-e063-6394a90aeb7dSPL set ID 07afce34-aaea-50a1-e054-00144ff88e88RxCUI 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
N461245008413followed by a unit qualifier and the quantityPackage 61245-0084-13. 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 61245-084
- What is NDC 61245-084?
- 61245-084 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 | 61245-085 | 61245-0085-13 |
Other NDCs under ANDA 079174
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 |
|---|---|---|---|---|
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Grocery Outlet, Inc. | 85828-110 |
| Medique at Home Iprinibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Unifirst First Aid Corporation | 47682-783 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | RETAIL BUSINESS SERVICES , LLC. | 72476-109 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | RETAIL BUSINESS SERVICES , LLC. | 72476-110 |
| Cabinet Pain Reliever and Fever Reduceribuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-0026 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | BETTER LIVING BRANDS LLC. | 21130-396 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-309 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceuticals LLC | 68210-4192 |
| McKesson Ibuprofen 200 mgibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | McKesson Medical-Surgical | 68599-8051 |
| Circle K Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Lil Drug Store Products, Inc | 66715-5507 |
| Ibuprofenibuprofen 200mg | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | ADVANCED FIRST AID, INC. | 67060-001 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-366 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-6114 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-365 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-8100 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-395 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-396 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | CVS PHARMACY, INC. | 69842-391 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | PuraCap Pharmaceutical LLC | 51013-319 |
| Ibuprofen, Caseys 4goodibuprofen tablets | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 66715-6307 |
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