Over-the-counter drug · ANDA
Ibuprofen NDC 55319-366
Ibuprofen 200 mg/1 · Tablet · Oral · Family Dollar
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55319-366-25 | 55319036625 | 250 TABLET in 1 BOTTLE (55319-366-25)Marketed from Nov 1, 2023 |
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
- Family DollarNDC labeler code 55319
- 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 55319-366_4654daa3-2e91-4b6a-e063-6294a90a26ebSPL ID 4654daa3-2e91-4b6a-e063-6294a90a26ebSPL set ID fe17f5a6-fd6d-d839-e053-6394a90a59a4RxCUI 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
N455319036625followed by a unit qualifier and the quantityPackage 55319-0366-25. 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 55319-366
- What is NDC 55319-366?
- 55319-366 is the product NDC for Ibuprofen, Ibuprofen 200 mg/1 tablet, listed with the FDA by Family Dollar. 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?
- Family Dollar, NDC labeler code 55319. 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?
- 663 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 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 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-070 | 72090-0070-01 |
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 |
|---|---|---|---|---|
| Physicians Care Ibuprofenibuprofen 200mg | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Acme United Corporation | 0924-0076 |
| Ibuwin Forteibuprofen | Ibuprofen 200 mg/1 | TabletOral | OPMX LLC | 69729-157 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Dr. Reddy's Laboratories Inc. | 75907-428 |
| Medique at Home Iprinibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Unifirst First Aid Corporation | 47682-783 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Dolgencorp, Inc. | 55910-847 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | BETTER LIVING BRANDS LLC. | 21130-396 |
| Cabinet Pain Reliever and Fever Reduceribuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-0026 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-309 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | RETAIL BUSINESS SERVICES , LLC. | 72476-109 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | RETAIL BUSINESS SERVICES , LLC. | 72476-110 |
| Ibuprofenibuprofen 200mg | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | ADVANCED FIRST AID, INC. | 67060-001 |
| Circle K Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Lil Drug Store Products, Inc | 66715-5507 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-4140 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceuticals LLC | 68210-4192 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | PuraCap Pharmaceutical LLC | 51013-319 |
| McKesson Ibuprofen 200 mgibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | McKesson Medical-Surgical | 68599-8051 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-365 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-366 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-395 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Spirit Pharmaceutical LLC | 68210-6114 |
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