Over-the-counter drug · ANDA
Ibuprofen and Diphenhydramine Citrate NDC 55111-565
Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 · Tablet · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-565-05 | 5511105650555111056505 | 1 BOTTLE in 1 CARTON (55111-565-05) / 500 TABLET in 1 BOTTLEMarketed from Jan 31, 2010 | |
| 55111-565-14 | 5511105651455111056514 | 1 BOTTLE in 1 CARTON (55111-565-14) / 20 TABLET in 1 BOTTLEMarketed from Jan 31, 2010 | |
| 55111-565-18 | 5511105651855111056518 | 1 BOTTLE in 1 CARTON (55111-565-18) / 180 TABLET in 1 BOTTLEMarketed from Jan 31, 2010 | |
| 55111-565-30 | 5511105653055111056530 | 1 BOTTLE in 1 CARTON (55111-565-30) / 30 TABLET in 1 BOTTLEMarketed from Jan 31, 2010 | |
| 55111-565-40 | 5511105654055111056540 | 1 BOTTLE in 1 CARTON (55111-565-40) / 40 TABLET in 1 BOTTLEMarketed from Jan 31, 2010 | |
| 55111-565-80 | 5511105658055111056580 | 1 BOTTLE in 1 CARTON (55111-565-80) / 80 TABLET in 1 BOTTLEMarketed from Jan 31, 2010 | |
| 55111-565-90 | 5511105659055111056590 | 1 BOTTLE in 1 CARTON (55111-565-90) / 90 TABLET in 1 BOTTLEMarketed from Jan 31, 2010 | |
| 55111-565-92 | 5511105659255111056592 | 2500 TABLET in 1 POUCH (55111-565-92)Marketed from Jan 31, 2010 |
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 Citrate
- Generic name (nonproprietary)
- ibuprofen and diphenhydramine citrate
- Active ingredients
- Ibuprofen — 200 mg/1Diphenhydramine citrate — 38 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories LimitedNDC labeler code 55111
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090619
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55111-565_d2953b94-9244-2c86-ac0c-7610dd1e7963SPL ID d2953b94-9244-2c86-ac0c-7610dd1e7963SPL set ID 42c06daf-541a-7721-b875-ea18364501a4RxCUI 895664UNII WK2XYI10QM, 4OD433S209
- 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
N455111056505followed by a unit qualifier and the quantityPackage 55111-0565-05. 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 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 55111-565
- What is NDC 55111-565?
- 55111-565 is the product NDC for Ibuprofen and Diphenhydramine Citrate, Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 8 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen and Diphenhydramine Citrate.
- What is the active ingredient?
- Ibuprofen, Diphenhydramine citrate.
- Who is the labeler?
- Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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 Citrate?
- 2 other product NDCs are listed under this name. See all Ibuprofen and Diphenhydramine Citrate 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 Diphenhydramine Citrate 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 Diphenhydramine Citrate | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | Better Living Brands, LLC | 21130-228 | 21130-0228-1221130-0228-1821130-0228-23+1 more |
| Ibuprofen and Diphenhydramine Citrate | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | Aurohealth LLC | 58602-867 | 58602-0867-0958602-0867-1258602-0867-14+14 more |