Proparacaine Hydrochloride
- Product NDC
- 61314-016
- 11-digit product format
- 613140016
- Labeler code
- 61314
- Product ID
- 61314-016_ca203740-1e54-4289-9a1f-f2086fec4f46
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Proparacaine Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Sandoz Inc.
- Application
- ANDA080027
- Marketing category
- ANDA
- Marketing start
- 2000-06-05
- 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 |
|---|
| 61314-016-01 | Proparacaine Hydrochloride | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | | 6 |
| 61314-016-01 | Proparacaine Hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61314-016 | PROPARACAINE HYDROCHLORIDE (PROPARACAINE HYDROCHLORIDE) SOLUTION/ DROPS [SANDOZ INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20220702_447a2a64-0507-4fe8-bb44-cc36c3916151.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 |
|---|
| 61314-016-01 | 61314001601 | 1 BOTTLE in 1 CARTON (61314-016-01) / 15 mL in 1 BOTTLE | 1 bottle | 2000-06-05 | 0000-00-00 | No | No | Current |