Tetracaine Hydrochloride
- Product NDC
- 70518-4183
- 11-digit product format
- 705184183
- Labeler code
- 70518
- Product ID
- 70518-4183_35bf62a6-b5a0-9582-e063-6394a90a1b92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tetracaine hydrochloride
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- REMEDYREPACK INC.
- Application
- NDA208135
- Marketing category
- NDA
- Marketing start
- 2024-09-24
- Substance
- TETRACAINE HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tetracaine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TETRACAINE HYDROCHLORIDE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5NF5D4OPCI |
| Rxcui | 1547771 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4183-0 | Tetracaine Hydrochloride | 12 in 1 CARTON | SOLUTION | 12 | | 2 |
| 70518-4183-1 | Tetracaine Hydrochloride | 4 mL in 1 BOTTLE, DROPPER | SOLUTION | 4 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4183 | TETRACAINE HYDROCHLORIDE SOLUTION [REMEDYREPACK INC.] | 2 | Current NDC, 2 package rows | 20250524_01fba5f8-a60a-444c-9abd-299540b8815a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4183-0 | 70518418300 | 12 BOTTLE, DROPPER in 1 CARTON (70518-4183-0) / 4 mL in 1 BOTTLE, DROPPER (70518-4183-1) | | 2024-09-24 | No | No | Historical |
| 70518-4183-1 | 70518418301 | 4 mL in 1 BOTTLE, DROPPER | 4 ml | | | | Historical |