Over-the-counter drug · ANDA
Ibuprofen NDC 81522-119
Ibuprofen 200 mg/1 · Tablet, Coated · Oral · FSA STORE INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81522-119-03 | 8152201190381522011903 | 1 BOTTLE, PLASTIC in 1 CARTON (81522-119-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from May 3, 2023 | |
| 81522-119-05 | 8152201190581522011905 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (81522-119-05)Marketed from Jan 11, 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, Coated
- Route
- Oral
- Labeler
- FSA STORE INC.NDC labeler code 81522
- 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 81522-119_37cb3dd7-010e-fc60-e063-6394a90ae846SPL ID 37cb3dd7-010e-fc60-e063-6394a90ae846SPL set ID ec6b015d-e72e-89c4-e053-2a95a90af81cRxCUI 310965UNII WK2XYI10QMUPC 0099581912062
- 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
N481522011903followed by a unit qualifier and the quantityPackage 81522-0119-03. 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 81522-119
- What is NDC 81522-119?
- 81522-119 is the product NDC for Ibuprofen, Ibuprofen 200 mg/1 tablet, coated, listed with the FDA by FSA STORE 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?
- FSA STORE INC., NDC labeler code 81522. 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?
- 673 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 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 |
|---|---|---|---|---|
| Dover Addaprinibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Unifirst First Aid Corporation | 47682-714 |
| Medique Iprinibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Unifirst First Aid Corporation | 47682-700 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | CVS | 51316-365 |
| Medi-First Plus Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Unifirst First Aid Corporation | 47682-709 |
| CAREALL Ibuprofenibuprofen | Ibuprofen 200 mg/1 | TabletOral | New World Imports | 51824-064 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | BETTER LIVING BRANDS LLC. | 21130-396 |
| Green Guard Ibuprofen Reliefibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Unifirst First Aid | 47682-710 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Dr. Reddy's Laboratories Inc. | 75907-428 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | HEB | 37808-109 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-268 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-209 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-210 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | RETAIL BUSINESS SERVICES , LLC. | 72476-110 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | RETAIL BUSINESS SERVICES , LLC. | 72476-109 |
| Lil Drug Store Ibuprofenibuprofen | Ibuprofen 200 mg/1 | TabletOral | Lil Drug Store Products, Inc | 66715-6839 |
| Medique at Home Iprinibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Unifirst First Aid Corporation | 47682-783 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Marc Glassman, Inc. | 68998-109 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Marc Glassman, Inc. | 68998-110 |
| Direct Safety Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Conney Safety Products, LLC | 61245-084 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules USA, Inc. | 69848-011 |
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