NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1218Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1218Add 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
71335-1218-0713351218007133512180021 TABLET, FILM COATED in 1 BOTTLE (71335-1218-0)Marketed from Feb 9, 2022
71335-1218-1713351218017133512180120 TABLET, FILM COATED in 1 BOTTLE (71335-1218-1)Marketed from Feb 9, 2022
71335-1218-2713351218027133512180215 TABLET, FILM COATED in 1 BOTTLE (71335-1218-2)Marketed from Feb 9, 2022
71335-1218-3713351218037133512180330 TABLET, FILM COATED in 1 BOTTLE (71335-1218-3)Marketed from Feb 9, 2022
71335-1218-4713351218047133512180440 TABLET, FILM COATED in 1 BOTTLE (71335-1218-4)Marketed from Feb 9, 2022
71335-1218-5713351218057133512180560 TABLET, FILM COATED in 1 BOTTLE (71335-1218-5)Marketed from Feb 9, 2022
71335-1218-6713351218067133512180690 TABLET, FILM COATED in 1 BOTTLE (71335-1218-6)Marketed from Feb 9, 2022
71335-1218-77133512180771335121807120 TABLET, FILM COATED in 1 BOTTLE (71335-1218-7)Marketed from Feb 9, 2022
71335-1218-8713351218087133512180850 TABLET, FILM COATED in 1 BOTTLE (71335-1218-8)Marketed from Feb 9, 2022
71335-1218-97133512180971335121809100 TABLET, FILM COATED in 1 BOTTLE (71335-1218-9)Marketed from Feb 9, 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 — 600 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091625
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 71335-1218_3018301b-f363-483b-bd7f-842bae77e2e7SPL ID 3018301b-f363-483b-bd7f-842bae77e2e7SPL set ID ffc953f7-ed92-4528-bb2f-72c634c119faRxCUI 197806UNII 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

N471335121800 followed by a unit qualifier and the quantity

Package 71335-1218-00. 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 71335-1218

What is NDC 71335-1218?
71335-1218 is the product NDC for Ibuprofen, Ibuprofen 600 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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?
674 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 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-478470518-4784-0070518-4784-01
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-478670518-4786-00
IbuprofenIbuprofen 200 mg/1TabletOralFamora Inc87509-000487509-0004-05
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralMedcore LLC82461-72582461-0725-90
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralMedcore LLC82461-72482461-0724-90
IbuprofenIbuprofen 200 mg/1TabletOralAurohealth LLC58602-91358602-0913-1758602-0913-40
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73867877-0738-0167877-0738-0567877-0738-30+3 more
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73767877-0737-0167877-0737-0567877-0737-33+1 more
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-73967877-0739-0167877-0739-0567877-0739-30+4 more
IbuprofenIbuprofen 200 mg/1Capsule, Liquid filledOralGOODSENSE50804-18550804-0185-0150804-0185-02

All 675 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 400 mg/1Tablet, Film coatedOralGranules India Limited62207-354
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0154
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralProficient Rx LP63187-967
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-044
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralProficient Rx LP63187-980
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralGranules Pharmaceuticals Inc.70010-066
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralGranules Pharmaceuticals Inc.70010-067
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralGranules Pharmaceuticals Inc.70010-068
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralProficient Rx LP63187-992
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 600 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-042
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0761
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-048
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3178
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1051
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralLegacy Pharmaceutical Packaging, LLC68645-563
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralLegacy Pharmaceutical Packaging, LLC68645-562
IbuprofenibuorofenIbuprofen 800 mg/1Tablet, Film coatedOralDirect_Rx61919-463

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