Tetracaine Hydrochloride
- Product NDC
- 70069-596
- 11-digit product format
- 700690596
- Labeler code
- 70069
- Product ID
- 70069-596_8d8c6ec7-7369-4f34-88bf-e8827fb87ef0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tetracaine Hydrochloride
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA217227
- Marketing category
- ANDA
- Marketing start
- 2024-12-23
- 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 |
|---|
| 70069-596-01 | Tetracaine Hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
| 70069-596-01 | Tetracaine Hydrochloride | 5 mL in 1 BOTTLE | SOLUTION | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-596 | TETRACAINE HYDROCHLORIDE SOLUTION [SOMERSET THERAPEUTICS, LLC] | 2 | Current NDC, 2 package rows | 20241223_bab63a18-3069-48a1-896e-433725f1dbaf.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 |
|---|
| 70069-596-01 | 70069059601 | 1 BOTTLE in 1 CARTON (70069-596-01) / 5 mL in 1 BOTTLE | 1 bottle | 2024-12-23 | No | No | Current |