What is NDC 68645-563?

68645-563 is the product NDC for Ibuprofen, Ibuprofen 800 mg/1 tablet, film coated, listed with the FDA by Legacy Pharmaceutical Packaging, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Legacy Pharmaceutical Packaging, LLC, NDC labeler code 68645. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ibuprofen NDC 68645-563 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68645-563Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68645-0563Add 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 NDC	11-digit (billing)	Package	Copy
68645-563-54	6864505635468645056354	30 TABLET, FILM COATED in 1 BOTTLE (68645-563-54)Marketed from Dec 21, 2015

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: Legacy Pharmaceutical Packaging, LLCNDC labeler code 68645
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091625
Marketing start: Dec 21, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 68645-563_4c4a254e-39fd-1e60-e063-6294a90a2703SPL ID 4c4a254e-39fd-1e60-e063-6294a90a2703SPL set ID 5ca441f9-a4b4-4bd8-aa54-319fae4c3d1aRxCUI 197806, 197807UNII WK2XYI10QMUPC 0368645562599, 0368645563541
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug

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

N468645056354 followed by a unit qualifier and the quantity

Package 68645-0563-54. 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 Mar 5, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & 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 68645-563

What is NDC 68645-563?: 68645-563 is the product NDC for Ibuprofen, Ibuprofen 800 mg/1 tablet, film coated, listed with the FDA by Legacy Pharmaceutical Packaging, LLC. It has 1 package NDC, 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?: Legacy Pharmaceutical Packaging, LLC, NDC labeler code 68645. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4784	70518-4784-0070518-4784-01
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4786	70518-4786-00
Ibuprofen	Ibuprofen 200 mg/1	TabletOral	Famora Inc	87509-0004	87509-0004-05
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Medcore LLC	82461-725	82461-0725-90
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Medcore LLC	82461-724	82461-0724-90
Ibuprofen	Ibuprofen 200 mg/1	TabletOral	Aurohealth LLC	58602-913	58602-0913-1758602-0913-40
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-738	67877-0738-0167877-0738-0567877-0738-30+3 more
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-737	67877-0737-0167877-0737-0567877-0737-33+1 more
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-739	67877-0739-0167877-0739-0567877-0739-30+4 more
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	GOODSENSE	50804-185	50804-0185-0150804-0185-02

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
Product	Strength	Form · route	Labeler	Product NDC
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	Granules India Limited	62207-354
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1218
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0154
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-967
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-044
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-980
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	Granules Pharmaceuticals Inc.	70010-066
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Granules Pharmaceuticals Inc.	70010-067
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Granules Pharmaceuticals Inc.	70010-068
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-992
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-319
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-320
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-321
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-042
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0761
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-048
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3178
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1051
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Legacy Pharmaceutical Packaging, LLC	68645-562
Ibuprofenibuorofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Direct_Rx	61919-463

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