Over-the-counter drug · ANDA
Dual Action (Acetaminophen, ibuprofen) NDC 21130-716
Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 · Tablet · Oral · BETTER LIVING BRANDS, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21130-716-08 | 2113007160821130071608 | 1 BOTTLE in 1 CARTON (21130-716-08) / 18 TABLET in 1 BOTTLEMarketed from Aug 30, 2023 | |
| 21130-716-75 | 2113007167521130071675 | 1 BOTTLE in 1 CARTON (21130-716-75) / 72 TABLET in 1 BOTTLEMarketed from Aug 30, 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
- Generic name (nonproprietary)
- acetaminophen, ibuprofen
- Active ingredients
- Acetaminophen — 250 mg/1Ibuprofen — 125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- BETTER LIVING BRANDS, LLCNDC labeler code 21130
- 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 21130-716_20402a78-3dea-b88c-e063-6294a90ab75aSPL ID 20402a78-3dea-b88c-e063-6294a90ab75aSPL set ID f2c096bb-cfed-bfa4-e053-2995a90af2cbRxCUI 2387532UNII 362O9ITL9D, 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
N421130071608followed by a unit qualifier and the quantityPackage 21130-0716-08. 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 21130-716
- What is NDC 21130-716?
- 21130-716 is the product NDC for Dual Action, Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 tablet, listed with the FDA by BETTER LIVING BRANDS, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dual Action (Acetaminophen, Ibuprofen).
- What is the active ingredient?
- Acetaminophen, Ibuprofen.
- Who is the labeler?
- BETTER LIVING BRANDS, LLC, NDC labeler code 21130. 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?
- 6 other product NDCs are listed under this name. See all Dual Action 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 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 Actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-542 | 72288-0542-01 |
| Dual Actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | HyVee Inc | 42507-540 | 42507-0540-23 |
| dual actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Publix Super Markets Inc | 56062-530 | 56062-0530-2356062-0530-68 |
| Dual Actionacetaminophen and ibuprofen (nsaid) tablets, 250 mg/ 125 mg | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc | 75907-158 | 75907-0158-1475907-0158-25 |
| Dual Actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | KROGER COMPANY | 41226-716 | 41226-0716-49 |
| dual actionacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Rite Aid Corporation | 11822-5777 | 11822-5777-0011822-5777-0111822-5777-02 |
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 | KROGER COMPANY | 41226-716 |
| Dual Action Pain Reliefacetaminophen, ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | TabletOral | TARGET CORPORATION | 11673-924 |
| Dual Action Pain Reliefacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-716 |