proparacaine hydrochloride
- Product NDC
- 68071-5139
- 11-digit product format
- 680715139
- Labeler code
- 68071
- Product ID
- 68071-5139_2abe0121-d9c6-92c1-e063-6294a90afa54
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- proparacaine hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA080027
- Marketing category
- ANDA
- Marketing start
- 1973-10-19
- 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 |
|---|
| 68071-5139-5 | proparacaine hydrochloride | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-5139 | PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250104_9a67a989-ec6b-4a26-e053-2a95a90a826d.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 |
|---|
| 68071-5139-5 | 68071513905 | 15 mL in 1 BOTTLE (68071-5139-5) | 15 ml | 2019-12-23 | 0000-00-00 | No | No | Current |