NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8757Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8757Add 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
68788-8757-16878887570168788875701100 TABLET, FILM COATED in 1 BOTTLE (68788-8757-1)Marketed from Oct 17, 2024
68788-8757-2687888757026878887570220 TABLET, FILM COATED in 1 BOTTLE (68788-8757-2)Marketed from Oct 17, 2024
68788-8757-3687888757036878887570330 TABLET, FILM COATED in 1 BOTTLE (68788-8757-3)Marketed from Oct 17, 2024
68788-8757-4687888757046878887570414 TABLET, FILM COATED in 1 BOTTLE (68788-8757-4)Marketed from Oct 17, 2024
68788-8757-5687888757056878887570550 TABLET, FILM COATED in 1 BOTTLE (68788-8757-5)Marketed from Oct 17, 2024
68788-8757-6687888757066878887570660 TABLET, FILM COATED in 1 BOTTLE (68788-8757-6)Marketed from Oct 17, 2024
68788-8757-7687888757076878887570721 TABLET, FILM COATED in 1 BOTTLE (68788-8757-7)Marketed from Oct 17, 2024
68788-8757-86878887570868788875708120 TABLET, FILM COATED in 1 BOTTLE (68788-8757-8)Marketed from Oct 17, 2024
68788-8757-9687888757096878887570990 TABLET, FILM COATED in 1 BOTTLE (68788-8757-9)Marketed from Oct 17, 2024

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 — 800 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202413
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 68788-8757_c300eff8-05c9-4eaf-9de8-16d02e44eb2aSPL ID c300eff8-05c9-4eaf-9de8-16d02e44eb2aSPL set ID b84ea215-e61d-4c00-8a34-d47c4080779bRxCUI 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

N468788875701 followed by a unit qualifier and the quantity

Package 68788-8757-01. 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 ]. 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 68788-8757

What is NDC 68788-8757?
68788-8757 is the product NDC for Ibuprofen, Ibuprofen 800 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 9 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 202413

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

FDA NDC Directory listings under ANDA 202413
ProductStrengthForm · routeLabelerProduct NDC
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralAiPing Pharmaceutical, Inc.11788-008
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralAiPing Pharmaceutical, Inc.11788-009
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralAiPing Pharmaceutical, Inc.11788-010
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7281
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7282
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7283
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7286
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7288
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7320
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7321
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7788
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7789
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7905
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-8122
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-8124
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-8137
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-8138
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-8141
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-8142
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralST. MARY'S MEDICAL PARK PHARMACY60760-844

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