Over-the-counter drug · ANDA
Acetaminophen and Ibuprofen Back Pain (Acetaminophen and ibuprofen) NDC 70010-213
Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 · Tablet · Oral · Granules Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70010-213-26 | 7001002132670010021326 | 1 BOTTLE in 1 CARTON (70010-213-26) / 18 TABLET in 1 BOTTLEMarketed from Jul 14, 2023 | |
| 70010-213-31 | 7001002133170010021331 | 288 TABLET in 1 BOTTLE (70010-213-31)Marketed from Jul 14, 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)
- Acetaminophen and Ibuprofen Back Pain
- Generic name (nonproprietary)
- acetaminophen and ibuprofen
- Active ingredients
- Acetaminophen — 250 mg/1Ibuprofen — 125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Granules Pharmaceuticals Inc.NDC labeler code 70010
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216592
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 70010-213_5d4ef213-9d46-6669-e063-6294a90a5242SPL ID 5d4ef213-9d46-6669-e063-6294a90a5242
- 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
N470010021326followed by a unit qualifier and the quantityPackage 70010-0213-26. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70010-213
- What is NDC 70010-213?
- 70010-213 is the product NDC for Acetaminophen and Ibuprofen Back Pain, Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 tablet, listed with the FDA by Granules Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen and Ibuprofen Back Pain (Acetaminophen and Ibuprofen).
- What is the active ingredient?
- Acetaminophen, Ibuprofen.
- Who is the labeler?
- Granules Pharmaceuticals Inc., NDC labeler code 70010. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acetaminophen and Ibuprofen Back Pain?
- 1 other product NDC are listed under this name. See all Acetaminophen and Ibuprofen Back Pain NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acetaminophen and Ibuprofen Back Pain products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Acetaminophen and Ibuprofen Back Painacetaminophen and ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-895 | 58602-0895-0158602-0895-0358602-0895-07+26 more |
Other NDCs under ANDA 216592
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 |
|---|---|---|---|---|
| Period Pills by Biikayacetaminophen, ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | Kai Squared | 85576-101 |
| Aacetaminophen and Ibuprofenacetaminophen and ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | GRANULES USA, INC. | 69848-588 |
| Acetaminophen and Ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | RUGBY LABORATORIES | 0536-1376 |
| Acetaminophen and Ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | Family Dollar | 55319-139 |
| Acetaminophen and Ibuprofen (NSAID) | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | TabletOral | Wal-Mart Stores Inc. | 79903-931 |
| Acetaminophen and Ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | TabletOral | CVS | 51316-131 |
| Acetaminophen and Ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | CVS | 51316-132 |
| Acetaminophen and Ibuprofen | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | TabletOral | WAL-MART STORES INC. | 79903-244 |
| Acetaminophen and Ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-131 |
| Acetaminophen and Ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | WALGREENS | 0363-9131 |
| Acetaminophen and Ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | LEADER/ Cardinal Health 110, Inc. | 70000-0622 |
| Acetaminophen and Ibuprofen (NSAID) | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | TabletOral | RITE AID | 11822-1131 |
| Dual Action Pain Relief | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | CapsuleOral | Allegiant Health | 69168-462 |
| Acetaminophen and Ibuprofen (NSAID) | Ibuprofen 125 mg/1; Acetaminophen 250 mg/1 | TabletOral | RETAIL BUSINESS SERVICES,LLC | 72476-131 |
| Acetaminophen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | RAONBIO CORP | 70038-131 |