Over-the-counter drug · ANDA
Unishield Ibuprofen (Ibuprofen) NDC 49314-1003
Ibuprofen 200 mg/1 · Tablet, Coated · Oral · Unishield
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49314-1003-3 | 4931410030349314100303 | 50 PACKET in 1 BOX (49314-1003-3) / 2 TABLET, COATED in 1 PACKETMarketed from Mar 1, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Unishield Ibuprofen
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- UnishieldNDC labeler code 49314
- 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 49314-1003_3e5d6ccc-f765-21b5-e063-6394a90a3400SPL ID 3e5d6ccc-f765-21b5-e063-6394a90a3400SPL set ID b9e2e2ba-e2ad-eace-e053-2995a90aed35RxCUI 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
N449314100303followed by a unit qualifier and the quantityPackage 49314-1003-03. 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 49314-1003
- What is NDC 49314-1003?
- 49314-1003 is the product NDC for Unishield Ibuprofen (ibuprofen), Ibuprofen 200 mg/1 tablet, coated, listed with the FDA by Unishield. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Unishield Ibuprofen (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Unishield, NDC labeler code 49314. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Unishield Ibuprofen?
- 1 other product NDC are listed under this name. See all Unishield Ibuprofen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Unishield 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) |
|---|---|---|---|---|---|
| Unishield Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Unishield | 49314-0993 | 49314-0993-03 |
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 | TabletOral | TOPCO ASSOCIATES LLC | 36800-663 |
| Ibuprofen Thompsonibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Thompson Safety | 73408-809 |
| Ibuprofen 200 Mgibuprofen | Ibuprofen 200 mg/1 | TabletOral | Basic Drugs, Inc. | 0761-0908 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Grocery Outlet, Inc. | 85828-110 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Lidl US LLC | 71141-114 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | BI-MART | 37835-585 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Bi-Mart | 37835-581 |
| Circle K Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Lil Drug Store Products, Inc | 66715-5507 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-309 |
| Ibuprofenibuprofen 200mg | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | ADVANCED FIRST AID, INC. | 67060-001 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-365 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-366 |
| McKesson Ibuprofen 200 mgibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | McKesson Medical-Surgical | 68599-8051 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-395 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-396 |
| Physicians Care Ibuprofenibuprofen 200mg | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Acme United Corporation | 0924-0076 |
| Ibuprofen, Caseys 4goodibuprofen tablets | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Lil' Drug Store Products, Inc. | 66715-6307 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | United Natural Foods, Inc. dba UNFI | 41163-509 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | PuraCap Pharmaceutical LLC | 51013-319 |
| Cabinet Pain Reliever and Fever Reduceribuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-0026 |
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