Over-the-counter drug · ANDA
Dual Action Pain Relief (Acetaminophen, ibuprofen) NDC 49483-716
Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 · Tablet · Oral · TIME CAP LABORATORIES, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-716-49 | 4948307164949483071649 | 1 BOTTLE in 1 CARTON (49483-716-49) / 144 TABLET in 1 BOTTLEMarketed from Oct 13, 2023 | |
| 49483-716-75 | 4948307167549483071675 | 1 BOTTLE in 1 CARTON (49483-716-75) / 72 TABLET in 1 BOTTLEMarketed from Oct 13, 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)
- Dual Action Pain Relief
- Generic name (nonproprietary)
- acetaminophen, ibuprofen
- Active ingredients
- Acetaminophen — 250 mg/1Ibuprofen — 125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INC.NDC labeler code 49483
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216994
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 49483-716_08acd3bf-ad0d-f693-e063-6394a90ad8c2SPL ID 08acd3bf-ad0d-f693-e063-6394a90ad8c2SPL set ID 08acd3bf-ad0c-f693-e063-6394a90ad8c2RxCUI 2387532UNII 362O9ITL9D, WK2XYI10QMUPC 0349483716757, 0349483716498
- 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
N449483071649followed by a unit qualifier and the quantityPackage 49483-0716-49. 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 toothache backache menstrual cramps muscular aches minor pain of arthritis
Excerpt only. Read the full label for complete information.
About NDC 49483-716
- What is NDC 49483-716?
- 49483-716 is the product NDC for Dual Action Pain Relief, Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 tablet, listed with the FDA by TIME CAP LABORATORIES, INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dual Action Pain Relief (Acetaminophen, Ibuprofen).
- What is the active ingredient?
- Acetaminophen, Ibuprofen.
- Who is the labeler?
- TIME CAP LABORATORIES, INC., NDC labeler code 49483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dual Action Pain Relief?
- 2 other product NDCs are listed under this name. See all Dual Action Pain Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dual Action Pain Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dual Action Pain Relief | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | CapsuleOral | Allegiant Health | 69168-462 | 69168-0462-0269168-0462-1769168-0462-35 |
| Dual Action Pain Reliefacetaminophen, ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | TabletOral | TARGET CORPORATION | 11673-924 | 11673-0924-75 |
Other NDCs under ANDA 216994
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 |
|---|---|---|---|---|
| Acetaminophen 250 mg and Ibuprofen 125 mgacetaminophen 250 mg and ibuprofen 125 mg tablets | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | MARKSANS PHARMA LIMITED | 25000-080 |
| Dual Actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | BETTER LIVING BRANDS, LLC | 21130-716 |
| Dual Actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | KROGER COMPANY | 41226-716 |
| Dual Action Pain Reliefacetaminophen, ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | TabletOral | TARGET CORPORATION | 11673-924 |