NDC codes

FDA NDC Directory
Product NDC (as listed)51655-385Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51655-0385Add 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
51655-385-265165503852690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-385-26)Marketed from Sep 8, 2022
51655-385-525165503855230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-385-52)Marketed from May 21, 2020

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
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 800 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Northwind Health Company, LLCNDC labeler code 51655
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091625
Marketing start
Marketing end
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 51655-385_541056be-a677-d141-e063-6394a90ab1a1SPL ID 541056be-a677-d141-e063-6394a90ab1a1SPL set ID ab80abe6-f7db-479b-e053-2a95a90a90e3RxCUI 197807UNII WK2XYI10QM

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

N451655038526 followed by a unit qualifier and the quantity

Package 51655-0385-26. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51655-385

What is NDC 51655-385?
51655-385 is the product NDC for Ibuprofen, Ibuprofen 800 mg/1 tablet, film coated, listed with the FDA by Northwind Health Company, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ibuprofen.
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Northwind Health Company, LLC, NDC labeler code 51655. 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?
664 other product NDCs are listed under this name. See all Ibuprofen 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
IbuprofenIbuprofen 200 mg/1TabletOralAurohealth LLC58602-91358602-0913-1758602-0913-40
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73967877-0739-0167877-0739-0567877-0739-30+4 more
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73767877-0737-0167877-0737-0567877-0737-33+1 more
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73867877-0738-0167877-0738-0567877-0738-30+3 more
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralGOODSENSE50804-18550804-0185-0150804-0185-02
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralShield Pharmaceuticals Corp83059-018083059-0180-04
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralGobrands, Inc. (Goodnow)82501-101082501-1010-00
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-474170518-4741-0070518-4741-02
IbuprofenIbuprofen 200 mg/1Tablet, CoatedOralP & L Development, LLC59726-00359726-0003-50
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-14372288-0143-7872288-0143-90

All 665 Ibuprofen NDCs

Other NDCs under ANDA 091625

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 091625
ProductStrengthForm · routeLabelerProduct NDC
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2629
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6645
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralBryant Ranch Prepack83615-0001
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralProficient Rx LP63187-967
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralGranules Pharmaceuticals Inc.70010-067
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralGranules Pharmaceuticals Inc.70010-066
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralGranules Pharmaceuticals Inc.70010-068
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralProficient Rx LP63187-980
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-319
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-320
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-321
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralProficient Rx LP63187-992
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3007
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralGranules India Limited62207-354
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralGranules India Limited62207-355
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralGranules India Limited62207-356
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3178
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralQPharma Inc42708-175
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-042
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1051

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