Prescription drug · ANDA

Ibuprofen NDC 63629-7676

Ibuprofen 400 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)63629-7676Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-7676Add 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
63629-7676-16362976760120 TABLET, FILM COATED in 1 BOTTLE (63629-7676-1)Marketed from Jul 25, 2018
63629-7676-26362976760230 TABLET, FILM COATED in 1 BOTTLE (63629-7676-2)Marketed from Feb 5, 2019
63629-7676-36362976760360 TABLET, FILM COATED in 1 BOTTLE (63629-7676-3)Marketed from Jun 15, 2018

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 — 400 mg/1
Dosage form
Tablet, Film coated
Route
Oral
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 63629-7676_36f8b88a-47ee-45ae-9e52-b402243200b0SPL ID 36f8b88a-47ee-45ae-9e52-b402243200b0SPL set ID f1c88d74-09b0-4b14-baea-106fbbbc54bfRxCUI 197805UNII 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

N463629767601 followed by a unit qualifier and the quantity

Package 63629-7676-01. 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 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)

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 coatedOralREMEDYREPACK INC.70518-0761
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralProficient Rx LP63187-980
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-321
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-319
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-320
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralQPharma Inc42708-175
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralProficient Rx LP63187-992
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralGranules India Limited62207-356
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralGranules India Limited62207-354
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralGranules India Limited62207-355
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralGranules Pharmaceuticals Inc.70010-068
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralGranules Pharmaceuticals Inc.70010-066
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralGranules Pharmaceuticals Inc.70010-067
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-042
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-048
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3178
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-044
IbuprofenIbuprofen 600 mg/1Tablet, Film coatedOralLegacy Pharmaceutical Packaging, LLC68645-562
IbuprofenIbuprofen 800 mg/1Tablet, Film coatedOralLegacy Pharmaceutical Packaging, LLC68645-563
IbuprofenIbuprofen 400 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1051

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