Over-the-counter drug · ANDA
Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg NDC 63548-0197
ibuprofen, diphenhydramine citrate · Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 · Tablet · Oral · PLD Acquisitions LLC DBA Avma Pharma Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63548-0197-2 | 63548019702 | 1 BOTTLE, PLASTIC in 1 BOX (63548-0197-2) / 20 TABLET in 1 BOTTLE, PLASTICMarketed from Apr 11, 2024 | |
| 63548-0197-3 | 63548019703 | 300 TABLET in 1 BOTTLE, PLASTIC (63548-0197-3)Marketed from Apr 11, 2024 | |
| 63548-0197-8 | 63548019708 | 8 TABLET in 1 BOTTLE, PLASTIC (63548-0197-8)Marketed from Apr 11, 2024 |
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 200 mg and Diphenhydramine Citrate 38 mg
- Generic name (nonproprietary)
- ibuprofen, diphenhydramine citrate
- Active ingredients
- Ibuprofen — 200 mg/1Diphenhydramine citrate — 38 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211404
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63548-0197_fbc47d79-348d-436e-ae3f-364d76f58e49SPL ID fbc47d79-348d-436e-ae3f-364d76f58e49SPL set ID a7d729bf-6d7a-415a-a414-cae0ba6d0063RxCUI 895664UNII WK2XYI10QM, 4OD433S209UPC 0000000000000
- Pharmacologic class
- Histamine-1 Receptor Antagonist; 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
N463548019702followed by a unit qualifier and the quantityPackage 63548-0197-02. 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 for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211404
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 PMdiphenhydramine citrate, ibuprofen | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | WR Group, Inc. | 69607-1970 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | Safeway, Inc. | 21130-056 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | Family Dollar (FAMILY WELLNESS) | 55319-197 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | WALMART INC. (see also Equate) | 79903-186 |