Prescription drug · ANDA
Tetracaine Hydrochloride NDC 70069-597
Tetracaine hydrochloride 5 mg/mL · Solution · Ophthalmic · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-597-01 | 7006905970170069059701 | 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, LLCNDC labeler code 70069
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217227
- Marketing start
- Listing expires
- 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
N470069059701followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 70069-597
- What is NDC 70069-597?
- 70069-597 is the product NDC for Tetracaine Hydrochloride, Tetracaine hydrochloride 5 mg/mL solution, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tetracaine Hydrochloride.
- What is the active ingredient?
- Tetracaine hydrochloride.
- Who is the labeler?
- Somerset Therapeutics, LLC, NDC labeler code 70069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tetracaine Hydrochloride?
- 10 other product NDCs are listed under this name. See all Tetracaine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tetracaine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tetracaine Hydrochloride | Tetracaine hydrochloride 5 mg/mL | SolutionOphthalmic | Somerset Therapeutics, LLC | 70069-596 | 70069-0596-01 |
| Tetracaine Hydrochloride | Tetracaine hydrochloride 5 mg/mL | SolutionOphthalmic | Sportpharm LLC | 85766-229 | 85766-0229-05 |
| Tetracaine Hydrochloride | Tetracaine hydrochloride 5 mg/mL | SolutionOphthalmic | Sportpharm LLC | 85766-230 | 85766-0230-15 |
| Tetracaine Hydrochloride | Tetracaine hydrochloride 5 mg/mL | SolutionOphthalmic | REMEDYREPACK INC. | 70518-4183 | 70518-4183-00 |
| Tetracaine Hydrochloride | Tetracaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-092 | 24208-0092-0524208-0092-15 |
| Tetracaine Hydrochloride | Tetracaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Americas Inc. | 82260-920 | 82260-0920-0582260-0920-15 |
| Tetracaine Hydrochloride | Tetracaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Bausch Health US LLC | 0187-0920 | 00187-0920-05 |
| Tetracaine Hydrochloride | Tetracaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Oceanside Pharmaceuticals | 68682-920 | 68682-0920-0568682-0920-64 |
| Tetracaine Hydrochloride | Tetracaine hydrochloride 5 mg/mL | SolutionOphthalmic | Alcon Laboratories, Inc. | 0065-0741 | 00065-0741-14 |
| Tetracaine Hydrochloride | Tetracaine hydrochloride 5 mg/mL | SolutionOphthalmic | A-S Medication Solutions | 50090-2364 | 50090-2364-01 |
Other NDCs under ANDA 217227
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tetracaine Hydrochloride | Tetracaine hydrochloride 5 mg/mL | SolutionOphthalmic | Somerset Therapeutics, LLC | 70069-596 |
| Tetracaine Hydrochloride | Tetracaine hydrochloride 5 mg/mL | SolutionOphthalmic | Sportpharm LLC | 85766-229 |
| Tetracaine Hydrochloride | Tetracaine hydrochloride 5 mg/mL | SolutionOphthalmic | Sportpharm LLC | 85766-230 |