NDC codes

FDA NDC Directory
Product NDC (as listed)51672-1409Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-1409Add 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
51672-1409-8516721409081 BOTTLE in 1 CARTON (51672-1409-8) / 118 mL in 1 BOTTLEMarketed from Jul 6, 2022
51672-1409-951672140909473 mL in 1 BOTTLE (51672-1409-9)Marketed from Jul 6, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 100 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209204
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 51672-1409_39624591-4c56-0f24-e063-6394a90ae7f7SPL ID 39624591-4c56-0f24-e063-6394a90ae7f7SPL set ID 398fbd9c-3a7f-4210-bedb-dfe2e7cbc43eRxCUI 197803UNII 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

N451672140908 followed by a unit qualifier and the quantity

Package 51672-1409-08. 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 oral suspension 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 ). In Pediatric Patients, Ibuprofen Oral Suspension is indicated: For reduction of fever in patients aged 6 months up to 2 years of age. For relief of mild to moderate pain in patients aged 6 months up to 2 years of age. For relief of signs and symptoms of juvenile arthritis. In Adults, Ibuprofen Oral Suspension is indicated: For treatment of primary dysmenorrhea. For relief of the signs and symptoms of rheumat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51672-1409

What is NDC 51672-1409?
51672-1409 is the product NDC for Ibuprofen, Ibuprofen 100 mg/5mL suspension, listed with the FDA by Sun Pharmaceutical Industries, Inc.. 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?
Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. 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 209204

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

FDA NDC Directory listings under ANDA 209204
ProductStrengthForm · routeLabelerProduct NDC
IbuprofenIbuprofen 100 mg/5mLSuspensionOralSun Pharmaceutical Industries, Inc.51672-1385
IbuprofenIbuprofen 100 mg/5mLSuspensionOralREMEDYREPACK INC.70518-4595

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