Over-the-counter drug · ANDA
Ibuprofen and Pseudoephedrine Hydrochloride NDC 11822-0084
Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 · Tablet, Coated · Oral · Rite-Aid
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11822-0084-5 | 1182200840511822008405 | 1 BLISTER PACK in 1 CARTON (11822-0084-5) / 20 TABLET, COATED in 1 BLISTER PACKMarketed from Feb 1, 2018 |
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)
- Ibuprofen and Pseudoephedrine Hydrochloride
- Generic name (nonproprietary)
- ibuprofen and pseudoephedrine hydrochloride
- Active ingredients
- Ibuprofen — 200 mg/1Pseudoephedrine hydrochloride — 30 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Rite-AidNDC labeler code 11822
- 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 11822-0084_57e8bb8d-b984-1d7b-e063-6294a90aab6bSPL ID 57e8bb8d-b984-1d7b-e063-6294a90aab6bSPL set ID 483c3bb7-529e-4684-80e1-6646b050988eRxCUI 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
N411822008405followed by a unit qualifier and the quantityPackage 11822-0084-05. 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 11822-0084
- What is NDC 11822-0084?
- 11822-0084 is the product NDC for Ibuprofen and Pseudoephedrine Hydrochloride, Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 tablet, coated, listed with the FDA by Rite-Aid. It has 1 package NDC, 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?
- Rite-Aid, NDC labeler code 11822. 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, Sugar coatedOral | Ohm Laboratories Inc. | 51660-423 | 51660-0423-2151660-0423-41 |
| 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, Sugar coatedOral | Ohm Laboratories Inc. | 51660-423 |
| 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 |