Proparacaine hydrochloride
- Product NDC
- 42571-497
- 11-digit product format
- 425710497
- Labeler code
- 42571
- Product ID
- 42571-497_41be90a9-dfee-6fcc-e063-6394a90a4124
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Proparacaine hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Micro Labs Limited
- Application
- ANDA219294
- Marketing category
- ANDA
- Marketing start
- 2026-02-01
- Substance
- PROPARACAINE HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Local Anesthesia [PE], Local Anesthetic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Proparacaine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROPARACAINE HYDROCHLORIDE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U96OL57GOY |
| Rxcui | 1191013 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42571-497-57 | Proparacaine hydrochloride | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | | 1 |
| 42571-497-57 | Proparacaine hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42571-497-57 | 42571049757 | 1 BOTTLE in 1 CARTON (42571-497-57) / 15 mL in 1 BOTTLE | 1 bottle | 2026-02-01 | No | No | Current |