Prescription drug · ANDA
Ibuprofen NDC 55154-1380
Ibuprofen 400 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-1380-0 | 55154138000 | 10 BLISTER PACK in 1 BAG (55154-1380-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 10, 2009 |
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)
- Ibuprofen
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 400 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Cardinal Health 107, LLCNDC labeler code 55154
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075682
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 55154-1380_bbd0e3a5-5432-41f7-816c-16ad6e240da0SPL ID bbd0e3a5-5432-41f7-816c-16ad6e240da0SPL set ID 8ea0e303-3967-4d71-8255-ac42a841ce28RxCUI 197805, 197806, 197807UNII WK2XYI10QMUPC 0055154138000, 0055154074100
- 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
N455154138000followed by a unit qualifier and the quantityPackage 55154-1380-00. 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 Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual 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 55154-1380
- What is NDC 55154-1380?
- 55154-1380 is the product NDC for Ibuprofen, Ibuprofen 400 mg/1 tablet, film coated, listed with the FDA by Cardinal Health 107, 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?
- Cardinal Health 107, LLC, NDC labeler code 55154. 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 800 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-739 | 67877-0739-0167877-0739-0567877-0739-30+4 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 600 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-738 | 67877-0738-0167877-0738-0567877-0738-30+3 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 075682
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 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-891 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-892 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9111 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9110 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1468 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9112 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0741 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-1342 |
| Ibuibuprofen | Ibuprofen 400 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-369 |
| Ibuibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-275 |
| Ibu | Ibuprofen 600 mg/1 | TabletOral | RedPharm Drug, Inc. | 67296-0913 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5853 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-841 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-839 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-840 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5854 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5855 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-969 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-967 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-968 |
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