Tetracaine Hydrochloride
- Product NDC
- 82260-920
- 11-digit product format
- 822600920
- Labeler code
- 82260
- Product ID
- 82260-920_4a468703-7613-0c8b-e063-6294a90a2f6e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tetracaine Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Bausch & Lomb Americas Inc.
- Application
- NDA210821
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2022-09-21
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tetracaine Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 82260-920-05 | Tetracaine Hydrochloride | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 4 |
| 82260-920-05 | Tetracaine Hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
| 82260-920-15 | Tetracaine Hydrochloride | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | | 4 |
| 82260-920-15 | Tetracaine Hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82260-920 | TETRACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB AMERICAS INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20240823_f12d5944-0d6c-43ff-89fd-e0b5669e9b4a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 82260-920-05 | 82260092005 | 1 BOTTLE, DROPPER in 1 CARTON (82260-920-05) / 5 mL in 1 BOTTLE, DROPPER | 2022-09-21 | 0000-00-00 | No | No | Current |
| 82260-920-15 | 82260092015 | 1 BOTTLE, DROPPER in 1 CARTON (82260-920-15) / 15 mL in 1 BOTTLE, DROPPER | 2022-09-21 | 0000-00-00 | No | No | Current |