Over-the-counter drug · ANDA
Assured Ibuprofen (Ibuprofen) NDC 68210-4139
Ibuprofen 200 mg/1 · Tablet, Film coated · Oral · Spirit Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68210-4139-4 | 6821041390468210413904 | 1 BOTTLE in 1 CARTON (68210-4139-4) / 40 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 28, 2021 |
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)
- Assured Ibuprofen
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Spirit Pharmaceuticals LLCNDC labeler code 68210
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202312
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 68210-4139_28ef5535-36c5-ed54-e063-6394a90aefc6SPL ID 28ef5535-36c5-ed54-e063-6394a90aefc6SPL set ID 119263b5-c3b7-46dc-a3bd-9893bfd24628RxCUI 310965UNII WK2XYI10QMUPC 0850026889123
- 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
N468210413904followed by a unit qualifier and the quantityPackage 68210-4139-04. 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 pain 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 68210-4139
- What is NDC 68210-4139?
- 68210-4139 is the product NDC for Assured Ibuprofen (ibuprofen), Ibuprofen 200 mg/1 tablet, film coated, listed with the FDA by Spirit Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Assured Ibuprofen (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Spirit Pharmaceuticals LLC, NDC labeler code 68210. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Assured Ibuprofen?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 202312
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 | Shield Pharmaceuticals Corp | 83059-0082 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | DISCOUNT DRUG MART | 53943-112 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | DISCOUNT DRUG MART | 53943-111 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | RETAIL BUSINESS SERVICES,LLC. | 72476-358 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-571 |
| Ibuprofen IBibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | WINCO FOODS, LLC | 67091-368 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-570 |
| Ibuprofen IBibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | WINCO FOODS, LLC | 67091-369 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Harris Teeter | 72036-211 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Harris Teeter | 72036-212 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Shield Pharmaceuticals Corp | 83059-0180 |
| Ibuprofen 200mg | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Athlete's Needs, Inc. | 53185-381 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | United Natural Foods, Inc. dba UNFI | 41163-116 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-865 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | United Natural Foods, Inc. dba UNFI | 41163-312 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-212 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-811 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | TOPCO ASSOCIATES LLC | 36800-662 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-320 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules India Limited | 62207-321 |
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