Tetracaine Hydrochloride NDC 70069-597

NDC codes

FDA NDC Directory

Product NDC (as listed)70069-597Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70069-0597Add 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
70069-597-01	70069059701	1 BOTTLE in 1 CARTON (70069-597-01) / 15 mL in 1 BOTTLEMarketed from Dec 23, 2024

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): Tetracaine Hydrochloride
Generic name (nonproprietary): tetracaine hydrochloride
Active ingredients: Tetracaine hydrochloride — 5 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Somerset Therapeutics, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217227
Marketing start: Dec 23, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Esters (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 70069-597_8d8c6ec7-7369-4f34-88bf-e8827fb87ef0SPL ID 8d8c6ec7-7369-4f34-88bf-e8827fb87ef0SPL set ID bab63a18-3069-48a1-896e-433725f1dbafRxCUI 1547771UNII 5NF5D4OPCIUPC 0370069596012, 0370069597019
Pharmacologic class: Ester Local Anesthetic

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

N470069059701 followed by a unit qualifier and the quantity

Package 70069-0597-01. 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 Dec 21, 2024.

Indications (excerpt from the label)

Tetracaine hydrochloride ophthalmic solution, 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine hydrochloride ophthalmic solution, 0.5%, is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217227

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

FDA NDC Directory listings under ANDA 217227
Product	Strength	Form · route	Labeler	Product NDC
Tetracaine Hydrochloride	Tetracaine hydrochloride 5 mg/mL	SolutionOphthalmic	Sportpharm LLC	85766-229
Tetracaine Hydrochloride	Tetracaine hydrochloride 5 mg/mL	SolutionOphthalmic	Sportpharm LLC	85766-230
Tetracaine Hydrochloride	Tetracaine hydrochloride 5 mg/mL	SolutionOphthalmic	Somerset Therapeutics, LLC	70069-596