Over-the-counter drug · ANDA
Ibuprofen NDC 53942-363
Ibuprofen 200 mg/1 · Capsule, Liquid filled · Oral · Demoulas Super Markets, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53942-363-20 | 5394203632053942036320 | 1 BOTTLE in 1 CARTON (53942-363-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Mar 30, 2021 | |
| 53942-363-40 | 5394203634053942036340 | 1 BOTTLE in 1 CARTON (53942-363-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Mar 30, 2021 | |
| 53942-363-80 | 5394203638053942036380 | 1 BOTTLE in 1 CARTON (53942-363-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Mar 30, 2021 |
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
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Demoulas Super Markets, Inc.NDC labeler code 53942
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079205
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 53942-363_da0964b8-957d-4658-afec-57b7a44d3601SPL ID da0964b8-957d-4658-afec-57b7a44d3601SPL set ID 1bb7dbc7-c087-44fa-bd12-d6b6e9975d57RxCUI 310964UNII 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
N453942036320followed by a unit qualifier and the quantityPackage 53942-0363-20. 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)
Use(s) temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 53942-363
- What is NDC 53942-363?
- 53942-363 is the product NDC for Ibuprofen, Ibuprofen 200 mg/1 capsule, liquid filled, listed with the FDA by Demoulas Super Markets, Inc.. It has 3 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?
- Demoulas Super Markets, Inc., NDC labeler code 53942. 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?
- 672 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 | REMEDYREPACK INC. | 70518-4801 | 70518-4801-00 |
| 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 |
Other NDCs under ANDA 079205
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 | Capsule, Liquid filledOral | MARKSANS PHARMA LIMITED | 25000-133 |
| Ibuprofen Minisibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Grocery Outlet, Inc. | 85828-700 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | BETTER LIVING BRANDS, LLC | 21130-070 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | WALGREENS | 0363-1610 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | BJWC (Berkley & Jensen / BJ's) | 68391-610 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | DOLGENCORP, INC. | 55910-399 |
| Proprinalibuprofen capsules 200 mg | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | A-S Medication Solutions | 50090-3507 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | TARGET CORPORATION | 11673-992 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | SPIRIT PHARMACEUTICALS,LLC | 68210-0200 |
| Ibuprofen 200 mgibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Allegiant Health | 69168-368 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Winco Foods, LLC | 67091-185 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Kroger Company | 41226-610 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | BETTER LIVING BRANDS, LLC | 21130-361 |
| Ibuprofenibuprofen capsules 200 mg | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC. | 49483-133 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | FSA STORE INC. | 81522-185 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | KROGER COMPANY | 41226-700 |
| Ibuprofen Miniibuprofen mini 200 mg | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | TARGET CORPORATION | 11673-683 |
| Sound Body Ibuprofenibuprofen 200 mg | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Allegiant Health | 69168-914 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | 49483-610 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | WALGREENS | 0363-8574 |
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