Prescription drug · ANDA
Ibuprofen NDC 49483-603
Ibuprofen 600 mg/1 · Tablet, Film coated · Oral · TIME CAP LABORATORIES, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-603-01 | 49483060301 | 100 TABLET, FILM COATED in 1 BOTTLE (49483-603-01)Marketed from Dec 30, 2015 | |
| 49483-603-03 | 49483060303 | 30 TABLET, FILM COATED in 1 BOTTLE (49483-603-03)Marketed from Dec 30, 2015 | |
| 49483-603-05 | 49483060305 | 50 TABLET, FILM COATED in 1 BOTTLE (49483-603-05)Marketed from Dec 30, 2015 | |
| 49483-603-50 | 49483060350 | 500 TABLET, FILM COATED in 1 BOTTLE (49483-603-50)Marketed from Dec 30, 2015 |
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 — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INCNDC labeler code 49483
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090796
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 49483-603_27b8b074-c62d-7214-e063-6294a90adb69SPL ID 27b8b074-c62d-7214-e063-6294a90adb69SPL set ID ec3e8443-d742-4c25-8516-f0df4ebfccdcRxCUI 197805, 197806, 197807UNII WK2XYI10QMUPC 0349483604504, 0349483604016, 0349483602012, 0349483602500, 0349483603507, 0349483603019
- 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
N449483060301followed by a unit qualifier and the quantityPackage 49483-0603-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.
Excerpt only. Read the full label for complete information.
About NDC 49483-603
- What is NDC 49483-603?
- 49483-603 is the product NDC for Ibuprofen, Ibuprofen 600 mg/1 tablet, film coated, listed with the FDA by TIME CAP LABORATORIES, INC. It has 4 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?
- 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?
- 664 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 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 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Shield Pharmaceuticals Corp | 83059-0180 | 83059-0180-04 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Gobrands, Inc. (Goodnow) | 82501-1010 | 82501-1010-00 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4741 | 70518-4741-0070518-4741-02 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | P & L Development, LLC | 59726-003 | 59726-0003-50 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-143 | 72288-0143-7872288-0143-90 |
Other NDCs under ANDA 090796
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 600 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4243 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | TIME CAP LABORATORIES, INC | 49483-602 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Direct Rx | 72189-324 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-097 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | TIME CAP LABORATORIES, INC | 49483-604 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0243 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-604 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-603 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-474 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4459 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1396 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5126 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5134 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5135 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-867 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-872 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5140 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-532 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-914 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0089 |
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