What is NDC 0023-5301?

0023-5301 is the product NDC for Restasis MultiDose (cyclosporine), Cyclosporine .5 mg/mL emulsion, listed with the FDA by Allergan, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Restasis MultiDose (Cyclosporine).

Allergan, Inc., NDC labeler code 0023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Restasis MultiDose?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Restasis MultiDose NDC 0023-5301 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0023-5301Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00023-5301Add 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
0023-5301-05	0002353010500023530105	1 BOTTLE in 1 CARTON (0023-5301-05) / 5.5 mL in 1 BOTTLEMarketed from Nov 10, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Restasis MultiDose
Generic name (nonproprietary): cyclosporine
Active ingredients: Cyclosporine — .5 mg/mL
Dosage form: Emulsion
Route: Ophthalmic
Labeler: Allergan, Inc.NDC labeler code 0023
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050790
Marketing start: Nov 10, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 0023-5301_6b6704de-6a92-4d21-8cb5-fbd1c2f3c489SPL ID 6b6704de-6a92-4d21-8cb5-fbd1c2f3c489SPL set ID 7224d810-bb96-4682-a942-3355e6e8061aRxCUI 351291, 402092UNII 83HN0GTJ6D
Pharmacologic class: Calcineurin Inhibitor Immunosuppressant

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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400023530105 followed by a unit qualifier and the quantity

Package 00023-5301-05. 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 Aug 21, 2025.

Indications (excerpt from the label)

RESTASIS MULTIDOSE ® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. RESTASIS MULTIDOSE is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0023-5301

What is NDC 0023-5301?: 0023-5301 is the product NDC for Restasis MultiDose (cyclosporine), Cyclosporine .5 mg/mL emulsion, listed with the FDA by Allergan, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Restasis MultiDose (Cyclosporine).
What is the active ingredient?: Cyclosporine.
Who is the labeler?: Allergan, Inc., NDC labeler code 0023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Restasis MultiDose?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 050790

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

FDA NDC Directory listings under NDA 050790
Product	Strength	Form · route	Labeler	Product NDC
Cyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	KVK-TECH, INC.	10702-808
Cyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Apotex Corp	60505-6202
Cyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Lupin Pharmaceuticals, Inc.	68180-214
Restasiscyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Allergan, Inc.	0023-9163
Restasiscyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	A-S Medication Solutions	50090-4476

Restasis MultiDose (Cyclosporine) NDC 0023-5301