Over-the-counter drug · ANDA
Ibuprofen NDC 53329-674
Ibuprofen 200 mg/1 · Tablet · Oral · Medline industries, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53329-674-30 | 53329067430 | 1 BOTTLE in 1 CARTON (53329-674-30) / 100 TABLET in 1 BOTTLEMarketed from Sep 29, 2017 |
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
- Medline industries, LPNDC labeler code 53329
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079174
- Marketing start
- Marketing end
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 53329-674_536feefb-4af9-5c62-e063-6294a90a3c95SPL ID 536feefb-4af9-5c62-e063-6294a90a3c95SPL set ID 5d2482b4-cd90-4246-85a9-fd1d35315b6cRxCUI 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
N453329067430followed by a unit qualifier and the quantityPackage 53329-0674-30. 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 53329-674
- What is NDC 53329-674?
- 53329-674 is the product NDC for Ibuprofen, Ibuprofen 200 mg/1 tablet, listed with the FDA by Medline industries, LP. 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?
- Medline industries, LP, NDC labeler code 53329. 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 | NUVICARE LLC | 84324-038 | 84324-0038-01 |
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 |
|---|---|---|---|---|
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-109 |
| Ibuprofen 200 Mg | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Farmacias De Similares TX LLC | 85786-107 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-909 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Harris Teeter | 72036-110 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Harris Teeter | 72036-109 |
| Uline Ibuprofenibuprofen | Ibuprofen 200 mg/1 | TabletOral | Uline | 69790-709 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-101 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Bi-Mart | 37835-581 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | BI-MART | 37835-585 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-268 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | CVS | 51316-365 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | TOPCO ASSOCIATES LLC | 36800-663 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Winco Foods, LLC | 67091-347 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Winco Foods, LLC | 67091-348 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-209 |
| CAREALL Ibuprofenibuprofen | Ibuprofen 200 mg/1 | TabletOral | New World Imports | 51824-064 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-210 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Grocery Outlet, Inc. | 85828-110 |
| Direct Safety Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Conney Safety Products, LLC | 61245-084 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | AMERIFOODS TRADING COMPANY | 61504-110 |
Showing 20 of 39.