Epinastine Hydrochloride NDC 70069-008

NDC codes

FDA NDC Directory

Product NDC (as listed)70069-008Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70069-0008Add 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
70069-008-01	70069000801	1 BOTTLE in 1 CARTON (70069-008-01) / 5 mL in 1 BOTTLEMarketed from Sep 14, 2016

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): Epinastine Hydrochloride
Generic name (nonproprietary): epinastine hydrochloride
Active ingredients: Epinastine hydrochloride — .5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Somerset Therapeutics, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090951
Marketing start: Sep 14, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic Agonists (Mechanism)Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 70069-008_a873a505-bb9c-4430-8921-8d800df991c7SPL ID a873a505-bb9c-4430-8921-8d800df991c7SPL set ID 0d4ee45c-e58f-4b7c-b389-898f5c27f54dRxCUI 860654UNII GFM415S5XLUPC 0370069008010
Pharmacologic class: Adrenergic Receptor Agonist; Histamine-1 Receptor Inhibitor

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

N470069000801 followed by a unit qualifier and the quantity

Package 70069-0008-01. 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 Mar 22, 2025.

Indications (excerpt from the label)

Epinastine HCl ophthalmic solution is an H 1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. Epinastine HCl ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)