Over-the-counter drug · ANDA
Ibuprofen (Ibupfrofen) NDC 49483-600
Ibuprofen 200 mg/1 · Tablet, Film coated · Oral · TIME CAP LABORATORIES,INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-600-01 | 4948306000149483060001 | 100 TABLET, FILM COATED in 1 BOTTLE (49483-600-01)Marketed from Mar 22, 2016 | |
| 49483-600-05 | 4948306000549483060005 | 50 TABLET, FILM COATED in 1 BOTTLE (49483-600-05)Marketed from Mar 22, 2016 | |
| 49483-600-50 | 4948306005049483060050 | 500 TABLET, FILM COATED in 1 BOTTLE (49483-600-50)Marketed from Nov 14, 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)
- ibupfrofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES,INCNDC labeler code 49483
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091239
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 49483-600_375d8923-4e92-d631-e063-6294a90a20ebSPL ID 375d8923-4e92-d631-e063-6294a90a20ebSPL set ID f58d35f9-e44b-417b-98ce-0766b537cd2fRxCUI 310965UNII WK2XYI10QMUPC 0349483600018, 0349483601015, 0349483600056, 0349483114171, 0349483600506
- 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
N449483060001followed by a unit qualifier and the quantityPackage 49483-0600-01. 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: o headache o toothache o backache o menstrual cramps o the common cold o muscular aches o minor pain of arthritis temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 49483-600
- What is NDC 49483-600?
- 49483-600 is the product NDC for Ibuprofen (ibupfrofen), Ibuprofen 200 mg/1 tablet, film coated, listed with the FDA by TIME CAP LABORATORIES,INC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen (Ibupfrofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- TIME CAP LABORATORIES,INC, NDC labeler code 49483. 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 091239
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 | MARKSANS PHARMA LIMITED | 25000-114 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-117 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Grocery Outlet, Inc. | 85828-601 |
| ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | DOLGENCORP INC | 55910-901 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | SAM'S WEST INC | 68196-601 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | RITE AID CORPORATION | 11822-7891 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | RITE AID CORPORATION | 11822-7892 |
| Ibuprofen Caibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | TARGET CORPORATION | 11673-990 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | TARGET CORPORATION | 11673-991 |
| Valumeds Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | SPIRIT PHARMACEUTICALS LLC | 68210-0800 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | WALGREENS | 0363-9600 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | BETTER LIVING BRANDS, LLC | 21130-261 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | WALGREENS | 0363-9601 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Kroger Company | 41226-600 |
| AeroTab Ibuprofenibuprofen tablet | Ibuprofen 200 mg/1000mg | Tablet, CoatedOral | Aero Healthcare | 55305-133 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | TIME CAP LABORATORIES,INC | 49483-114 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | TIME CAP LABORATORIES,INC | 49483-601 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | BETTER LIVING BRANDS, LLC | 21130-006 |