NDC codes

FDA NDC Directory
Product NDC (as listed)55111-565Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0565Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
55111-565-0555111056505551110565051 BOTTLE in 1 CARTON (55111-565-05) / 500 TABLET in 1 BOTTLEMarketed from Jan 31, 2010
55111-565-1455111056514551110565141 BOTTLE in 1 CARTON (55111-565-14) / 20 TABLET in 1 BOTTLEMarketed from Jan 31, 2010
55111-565-1855111056518551110565181 BOTTLE in 1 CARTON (55111-565-18) / 180 TABLET in 1 BOTTLEMarketed from Jan 31, 2010
55111-565-3055111056530551110565301 BOTTLE in 1 CARTON (55111-565-30) / 30 TABLET in 1 BOTTLEMarketed from Jan 31, 2010
55111-565-4055111056540551110565401 BOTTLE in 1 CARTON (55111-565-40) / 40 TABLET in 1 BOTTLEMarketed from Jan 31, 2010
55111-565-8055111056580551110565801 BOTTLE in 1 CARTON (55111-565-80) / 80 TABLET in 1 BOTTLEMarketed from Jan 31, 2010
55111-565-9055111056590551110565901 BOTTLE in 1 CARTON (55111-565-90) / 90 TABLET in 1 BOTTLEMarketed from Jan 31, 2010
55111-565-9255111056592551110565922500 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

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

N455111056505 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ibuprofen and Diphenhydramine Citrate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ibuprofen and Diphenhydramine CitrateIbuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1Tablet, CoatedOralBetter Living Brands, LLC21130-22821130-0228-1221130-0228-1821130-0228-23+1 more
Ibuprofen and Diphenhydramine CitrateIbuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1Tablet, CoatedOralAurohealth LLC58602-86758602-0867-0958602-0867-1258602-0867-14+14 more

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