What is NDC 64380-997?

64380-997 is the product NDC for Ibuprofen, Ibuprofen 100 mg/5mL suspension, listed with the FDA by Strides Pharma Science Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Strides Pharma Science Limited, NDC labeler code 64380. 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?

664 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 64380-997 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-997Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0997Add 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
64380-997-03	64380099703	1 BOTTLE in 1 CARTON (64380-997-03) / 118 mL in 1 BOTTLEMarketed from Sep 19, 2023
64380-997-04	64380099704	473 mL in 1 BOTTLE (64380-997-04)Marketed from Sep 19, 2023

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 — 100 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: Strides Pharma Science LimitedNDC labeler code 64380
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215311
Marketing start: Sep 19, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 64380-997_ac237016-385d-4874-9f6b-795ba4c88489SPL ID ac237016-385d-4874-9f6b-795ba4c88489SPL set ID 38ebacc3-378f-483e-babc-76119677e7dfRxCUI 197803UNII WK2XYI10QMUPC 0364380997047, 0364380997030
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

N464380099703 followed by a unit qualifier and the quantity

Package 64380-0997-03. 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 Jul 15, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ibuprofen oral suspension 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 ). In Pediatric Patients, ibuprofen oral suspension is indicated: For reduction of fever in patients aged 6 months up to 2 years of age. For relief of mild to moderate pain in patients aged 6 months up to 2 years of age. For relief of signs and symptoms of juvenile arthritis. In Adults, ibuprofen oral suspension is indicated: For treatment of primary dysmenorrhea. For relief of the signs and symptoms of rheumat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64380-997

What is NDC 64380-997?: 64380-997 is the product NDC for Ibuprofen, Ibuprofen 100 mg/5mL suspension, listed with the FDA by Strides Pharma Science Limited. It has 2 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?: Strides Pharma Science Limited, NDC labeler code 64380. 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?: 664 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 200 mg/1	TabletOral	Aurohealth LLC	58602-913	58602-0913-1758602-0913-40
Ibuprofen	Ibuprofen 800 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-739	67877-0739-0167877-0739-0567877-0739-30+4 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 600 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-738	67877-0738-0167877-0738-0567877-0738-30+3 more
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	GOODSENSE	50804-185	50804-0185-0150804-0185-02
Ibuprofen	Ibuprofen 200 mg/1	Tablet, CoatedOral	Shield Pharmaceuticals Corp	83059-0180	83059-0180-04
Ibuprofen	Ibuprofen 200 mg/1	Capsule, Liquid filledOral	Gobrands, Inc. (Goodnow)	82501-1010	82501-1010-00
Ibuprofen	Ibuprofen 600 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4741	70518-4741-0070518-4741-02
Ibuprofen	Ibuprofen 200 mg/1	Tablet, CoatedOral	P & L Development, LLC	59726-003	59726-0003-50
Ibuprofen	Ibuprofen 200 mg/1	Tablet, Film coatedOral	Amazon.com Services LLC	72288-143	72288-0143-7872288-0143-90

All 665 Ibuprofen NDCs