What is NDC 69238-1103?

69238-1103 is the product NDC for Ibuprofen, Ibuprofen 800 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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 69238-1103 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-1103Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-1103Add 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
69238-1103-5	6923811030569238110305	500 TABLET, FILM COATED in 1 BOTTLE (69238-1103-5)Marketed from Apr 1, 2014

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: Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078329
Marketing start: Apr 1, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 69238-1103_9fdca868-ff3e-4871-9921-9ef7adc577e5SPL ID 9fdca868-ff3e-4871-9921-9ef7adc577e5SPL set ID e07d989d-1b0e-4cc1-abf2-93c8b208a29aRxCUI 197805, 197806, 197807UNII WK2XYI10QMUPC 0369238110159, 0369238110357, 0369238110258
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

N469238110305 followed by a unit qualifier and the quantity

Package 69238-1103-05. 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 Dec 30, 2023. 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 69238-1103

What is NDC 69238-1103?: 69238-1103 is the product NDC for Ibuprofen, Ibuprofen 800 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals NY 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?: Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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 078329

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

FDA NDC Directory listings under ANDA 078329
Product	Strength	Form · route	Labeler	Product NDC
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8309
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8310
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8311
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5818
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5819
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-596
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-597
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-807
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-808
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-809
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4845
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4887
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4949
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4952
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4968
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-5066
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-5228
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8531
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8710
Ibuprofen	Ibuprofen 400 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals NY LLC	69238-1101

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