Over-the-counter drug · ANDA
Ibuprofen NDC 51013-319
Ibuprofen 200 mg/1 · Tablet · Oral · PuraCap Pharmaceutical LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51013-319-54 | 5101303195451013031954 | 15 POUCH in 1 CARTON (51013-319-54) / 2 TABLET in 1 POUCHMarketed from Nov 9, 2017 |
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)
- Ibuprofen
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PuraCap Pharmaceutical LLCNDC labeler code 51013
- 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 51013-319_127ceac7-923c-47f4-a768-47f7e46b2e97SPL ID 127ceac7-923c-47f4-a768-47f7e46b2e97SPL set ID acc4cbc8-085d-42f3-ad93-113e0b55631cRxCUI 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
N451013031954followed by a unit qualifier and the quantityPackage 51013-0319-54. 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: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 51013-319
- What is NDC 51013-319?
- 51013-319 is the product NDC for Ibuprofen, Ibuprofen 200 mg/1 tablet, listed with the FDA by PuraCap Pharmaceutical LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen.
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- PuraCap Pharmaceutical LLC, NDC labeler code 51013. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ibuprofen?
- 674 other product NDCs are listed under this name. See all Ibuprofen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other 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) |
|---|---|---|---|---|---|
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4784 | 70518-4784-0070518-4784-01 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4786 | 70518-4786-00 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Famora Inc | 87509-0004 | 87509-0004-05 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-725 | 82461-0725-90 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-724 | 82461-0724-90 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Aurohealth LLC | 58602-913 | 58602-0913-1758602-0913-40 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-738 | 67877-0738-0167877-0738-0567877-0738-30+3 more |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-737 | 67877-0737-0167877-0737-0567877-0737-33+1 more |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-739 | 67877-0739-0167877-0739-0567877-0739-30+4 more |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | GOODSENSE | 50804-185 | 50804-0185-0150804-0185-02 |
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 |
| Unishield Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Unishield | 49314-1003 |
| 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 |
| Cabinet Pain Reliever and Fever Reduceribuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-0026 |
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