Over-the-counter drug · ANDA
Ibuprofen and Diphenhydramine HCl (Ibuprofen, diphenhydramine hcl) NDC 63941-682
Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 · Capsule, Liquid filled · Oral · VALU MERCHANDISERS COMPANY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63941-682-15 | 6394106821563941068215 | 1 BOTTLE in 1 CARTON (63941-682-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Oct 3, 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)
- Ibuprofen and Diphenhydramine HCl
- Generic name (nonproprietary)
- ibuprofen, diphenhydramine hcl
- Active ingredients
- Ibuprofen — 200 mg/1Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- VALU MERCHANDISERS COMPANYNDC labeler code 63941
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090397
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63941-682_06d3d2fc-a073-863f-e063-6394a90a2374SPL ID 06d3d2fc-a073-863f-e063-6394a90a2374SPL set ID fed2f7ae-2827-f967-e053-6294a90adc0aRxCUI 901814UNII WK2XYI10QM, TC2D6JAD40
- 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
N463941068215followed by a unit qualifier and the quantityPackage 63941-0682-15. 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.
About NDC 63941-682
- What is NDC 63941-682?
- 63941-682 is the product NDC for Ibuprofen and Diphenhydramine HCl, Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 capsule, liquid filled, listed with the FDA by VALU MERCHANDISERS COMPANY. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen and Diphenhydramine HCl (Ibuprofen, Diphenhydramine HCl).
- What is the active ingredient?
- Ibuprofen, Diphenhydramine hydrochloride.
- Who is the labeler?
- VALU MERCHANDISERS COMPANY, NDC labeler code 63941. 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 Diphenhydramine HCl?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 090397
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 PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | WALGREEN COMPANY | 0363-0207 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | KROGER COMPANY | 30142-232 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | TOP CARE (Topco Associates LLC) | 36800-237 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | MEIJER DISTRIBUTION INC. | 41250-285 |
| Ibuprofen PMibuprofen and diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Whole Foods Market, INC. | 42681-0061 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Wal-Mart Stores, Inc. | 49035-670 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | HEB | 59640-020 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | CHAIN DRUG MARKETING ASSOCIATION INC. | 63868-829 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Premier Value Alliance LLC | 68016-057 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | CVS Pharmacy | 69842-870 |
| Ibuprofen, Diphenhydramine HCl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | TARGET Corporation | 11673-225 |
| Ibuprofen, Diphenhydramine HCl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Rite Aid Corporation | 11822-0789 |
| Ibuprofen, Diphenhydramine HCl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Bionpharma Inc. | 69452-205 |
| pain relief pmibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Bionpharma Inc. | 69452-264 |
| pain relief pmibuprofen and diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Bionpharma Inc. | 69452-507 |