Over-the-counter drug · ANDA
Ibuprofen and Pseudoephedrine hydrochloride NDC 51660-423
Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 · Tablet, Sugar coated · Oral · Ohm Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51660-423-21 | 5166004232151660042321 | 20 TABLET, SUGAR COATED in 1 BLISTER PACK (51660-423-21)Marketed from Oct 13, 2001 | |
| 51660-423-41 | 5166004234151660042341 | 40 TABLET, SUGAR COATED in 1 BLISTER PACK (51660-423-41)Marketed from Oct 13, 2001 |
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 and Pseudoephedrine hydrochloride
- Generic name (nonproprietary)
- ibuprofen and pseudoephedrine hydrochloride
- Active ingredients
- Ibuprofen — 200 mg/1Pseudoephedrine hydrochloride — 30 mg/1
- Dosage form
- Tablet, Sugar coated
- Route
- Oral
- Labeler
- Ohm Laboratories Inc.NDC labeler code 51660
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074567
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 51660-423_2f1cab21-cfa7-0b0e-e063-6294a90a9ae6SPL ID 2f1cab21-cfa7-0b0e-e063-6294a90a9ae6SPL set ID 65ec0f85-7ca3-4adc-b152-a0ae2fd0692fRxCUI 1299021UNII WK2XYI10QM, 6V9V2RYJ8N
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug; alpha-Adrenergic Agonist
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
N451660042321followed by a unit qualifier and the quantityPackage 51660-0423-21. 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 these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains
Excerpt only. Read the full label for complete information.
About NDC 51660-423
- What is NDC 51660-423?
- 51660-423 is the product NDC for Ibuprofen and Pseudoephedrine hydrochloride, Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 tablet, sugar coated, listed with the FDA by Ohm Laboratories Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen and Pseudoephedrine hydrochloride.
- What is the active ingredient?
- Ibuprofen, Pseudoephedrine hydrochloride.
- Who is the labeler?
- Ohm Laboratories Inc., NDC labeler code 51660. 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 and Pseudoephedrine hydrochloride?
- 4 other product NDCs are listed under this name. See all Ibuprofen and Pseudoephedrine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ibuprofen and Pseudoephedrine hydrochloride 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 and Pseudoephedrine Hydrochloride | Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 | Tablet, CoatedOral | Aurohealth LLC | 58602-839 | 58602-0839-13 |
| Ibuprofen and Pseudoephedrine Hydrochloride | Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 | Tablet, CoatedOral | Rite-Aid | 11822-0084 | 11822-0084-05 |
| Ibuprofen and Pseudoephedrine Hydrochloride | Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 | Tablet, Sugar coatedOral | Publix Super Markets Inc | 56062-423 | 56062-0423-41 |
| Ibuprofen and Pseudoephedrine Hydrochloride | Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 | Tablet, Sugar coatedOral | Strategic Sourcing Services LLC | 62011-0070 | 62011-0070-01 |
Other NDCs under ANDA 074567
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 and Pseudoephedrine Hydrochloride | Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 | Tablet, CoatedOral | Rite-Aid | 11822-0084 |
| Ibuprofen and Pseudoephedrine Hydrochloride | Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 | Tablet, Sugar coatedOral | Publix Super Markets Inc | 56062-423 |
| Ibuprofen and Pseudoephedrine Hydrochloride | Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 | Tablet, Sugar coatedOral | Strategic Sourcing Services LLC | 62011-0070 |