Tetracaine Hydrochloride
- Product NDC
- 0187-0920
- 11-digit product format
- 001870920
- Labeler code
- 0187
- Product ID
- 0187-0920_453da1ac-7306-7a40-e063-6394a90a741c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tetracaine Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Bausch Health US LLC
- 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 |
|---|
| 0187-0920-05 | Tetracaine Hydrochloride | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 2 |
| 0187-0920-05 | Tetracaine Hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0187-0920 | TETRACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH HEALTH US LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20200417_78404c9e-9c31-4b0a-90f4-04182e82e183.zip |
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 |
|---|
| 0187-0920-05 | 00187092005 | 1 BOTTLE in 1 CARTON (0187-0920-05) / 5 mL in 1 BOTTLE | 1 bottle | 2019-06-27 | 2027-04-30 | No | No | Current |