Over-the-counter drug · ANDA
Ibuprofen NDC 50844-353
Ibuprofen 200 mg/1 · Tablet, Film coated · Oral · L.N.K. International, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50844-353-02 | 5084403530250844035302 | 1 BOTTLE, PLASTIC in 1 CARTON (50844-353-02) / 12 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 1, 1999 | |
| 50844-353-16 | 5084403531650844035316 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-353-16)Marketed from Mar 1, 1999 |
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, Film coated
- Route
- Oral
- Labeler
- L.N.K. International, Inc.NDC labeler code 50844
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075139
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 50844-353_5f8c5841-a57f-4394-bbc2-93fc48474282SPL ID 5f8c5841-a57f-4394-bbc2-93fc48474282SPL set ID c93da67f-f42e-4baa-976b-73c71ba6dd71RxCUI 310965UNII WK2XYI10QMUPC 0050844353169
- 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
N450844035302followed by a unit qualifier and the quantityPackage 50844-0353-02. 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 toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 50844-353
- What is NDC 50844-353?
- 50844-353 is the product NDC for Ibuprofen, Ibuprofen 200 mg/1 tablet, film coated, listed with the FDA by L.N.K. International, Inc.. It has 2 package NDCs, 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?
- L.N.K. International, Inc., NDC labeler code 50844. 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 600 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-724 | 82461-0724-90 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-725 | 82461-0725-90 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Aurohealth LLC | 58602-913 | 58602-0913-1758602-0913-40 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-737 | 67877-0737-0167877-0737-0567877-0737-33+1 more |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-738 | 67877-0738-0167877-0738-0567877-0738-30+3 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 075139
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, Film coatedOral | Cardinal Health 107, LLC | 55154-0669 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Topco Associates, LLC | 36800-993 |
| Dye Free Ibuprofenibuprofen | Ibuprofen 200 mg/1 | TabletOral | Breeden Brothers, LLC | 70729-002 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. DBA Leader | 70000-0291 |
| Ibuprofen Dye-Freeibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Wal-Mart Stores Inc | 49035-438 |
| Ibuprofen Dye Freeibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | WALMART INC. | 79903-415 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | H E B | 37808-393 |
| pain relief ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Rite Aid Corporation | 11822-0392 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Rite Aid Corporation | 11822-0393 |
| Dye Free Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-4381 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-993 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | ARMY AND AIR FORCE EXCHANGE SERVICE | 55301-392 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7914 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | COSTCO WHOLESALE CORPORATION | 63981-393 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | ARMY AND AIR FORCE EXCHANGE SERVICE | 55301-393 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Meijer Distribution, Inc. | 79481-0392 |
| Dye Free Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-0438 |
| Ibuprofen Dye Freeibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 59779-438 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Family Dollar Services Inc | 55319-893 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | L.N.K. International, Inc. | 50844-352 |
Showing 20 of 24.