Over-the-counter drug · ANDA
Ibuprofen PM (Diphenhydramine citrate, ibuprofen) NDC 55319-197
Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 · Tablet, Coated · Oral · Family Dollar (FAMILY WELLNESS)
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55319-197-20 | 5531901972055319019720 | 1 BOTTLE, PLASTIC in 1 BOX (55319-197-20) / 20 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Mar 1, 2024 | |
| 55319-197-40 | 5531901974055319019740 | 1 BOTTLE, PLASTIC in 1 BOX (55319-197-40) / 40 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Mar 1, 2024 |
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 PM
- Generic name (nonproprietary)
- diphenhydramine citrate, ibuprofen
- Active ingredients
- Ibuprofen — 200 mg/1Diphenhydramine citrate — 38 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Family Dollar (FAMILY WELLNESS)NDC labeler code 55319
- 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 55319-197_bf93acc7-e377-45cc-b9f4-269b516e0c6aSPL ID bf93acc7-e377-45cc-b9f4-269b516e0c6aSPL set ID e01be0d7-e16d-44f1-9a0c-251ff9a65d28RxCUI 895664UNII WK2XYI10QM, 4OD433S209UPC 0032251920943
- 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
N455319019720followed by a unit qualifier and the quantityPackage 55319-0197-20. 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 55319-197
- What is NDC 55319-197?
- 55319-197 is the product NDC for Ibuprofen PM, Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 tablet, coated, listed with the FDA by Family Dollar (FAMILY WELLNESS). It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen PM (Diphenhydramine Citrate, Ibuprofen).
- What is the active ingredient?
- Ibuprofen, Diphenhydramine citrate.
- Who is the labeler?
- Family Dollar (FAMILY WELLNESS), NDC labeler code 55319. 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 PM?
- 24 other product NDCs are listed under this name. See all Ibuprofen PM NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ibuprofen PM 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 PMibuprofen and diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Whole Foods Market, INC. | 42681-0061 | 42681-0061-01 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | HEB | 59640-020 | 59640-0020-15 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Safeway | 21130-623 | 21130-0623-76 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | WR Group, Inc. | 69607-1970 | 69607-1970-01 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | WALMART INC. (see also Equate) | 79903-186 | 79903-0186-2079903-0186-80 |
| Ibuprofen PMibuprofen and diphenhydramine citrate | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | KROGER COMPANY | 30142-278 | 30142-0278-80 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | Safeway, Inc. | 21130-056 | 21130-0056-4021130-0056-80 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | CVS Pharmacy | 69842-870 | 69842-0870-15 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | TOP CARE (Topco Associates LLC) | 36800-237 | 36800-0237-15 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | KROGER COMPANY | 30142-232 | 30142-0232-1530142-0232-78 |
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 200 mg and Diphenhydramine Citrate 38 mgibuprofen, diphenhydramine citrate | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | TabletOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-0197 |
| 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 | WR Group, Inc. | 69607-1970 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | WALMART INC. (see also Equate) | 79903-186 |