Proparacaine Hydrochloride
- Product NDC
- 68071-4368
- 11-digit product format
- 680714368
- Labeler code
- 68071
- Product ID
- 68071-4368_1a555cda-0c40-ba30-e063-6394a90a3525
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Proparacaine Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA040074
- Marketing category
- ANDA
- Marketing start
- 1995-09-29
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4368-5 | Proparacaine Hydrochloride | 15 mL in 1 BOX | SOLUTION/ DROPS | 15 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4368 | PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240608_68a84d3f-a8f8-13ee-e053-2991aa0a7592.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 |
|---|
| 68071-4368-5 | 68071436805 | 15 mL in 1 BOX (68071-4368-5) | 15 ml | 2018-03-30 | 0000-00-00 | No | No | Current |