Tetracaine Hydrochloride
- Product NDC
- 68682-920
- 11-digit product format
- 686820920
- Labeler code
- 68682
- Product ID
- 68682-920_48ec9821-6f9b-2a1b-e063-6394a90a1d98
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tetracaine Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Oceanside Pharmaceuticals
- Application
- NDA210821
- Marketing category
- NDA
- Marketing start
- 2019-06-27
- Marketing end
- 2027-04-30
- Substance
- TETRACAINE HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tetracaine Hydrochloride
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 |
|---|
| 68682-920-05 | Tetracaine Hydrochloride | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 6 |
| 68682-920-05 | Tetracaine Hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 6 |
| 68682-920-64 | Tetracaine Hydrochloride | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | | 6 |
| 68682-920-64 | Tetracaine Hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68682-920-05 | 68682092005 | 1 BOTTLE in 1 CARTON (68682-920-05) / 5 mL in 1 BOTTLE | 1 bottle | 2020-04-05 | 2027-04-30 | No | No | Current |
| 68682-920-64 | 68682092064 | 1 BOTTLE in 1 CARTON (68682-920-64) / 15 mL in 1 BOTTLE | 1 bottle | 2019-06-27 | 2027-04-30 | No | No | Current |