Proparacaine Hydrochloride
- Product NDC
- 21695-530
- 11-digit product format
- 216950530
- Labeler code
- 21695
- Product ID
- 21695-530_c1e57227-6c96-4922-973e-74838ab4c795
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Proparacaine Hydrochloride
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Rebel Distributors Corp
- Application
- ANDA040074
- Marketing category
- ANDA
- Marketing start
- 1995-09-29
- Marketing end
- 0000-00-00
- Substance
- PROPARACAINE HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Local Anesthesia [PE],Local Anesthetic [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9ba0893a-4390-4124-b66b-ffd4f2b29a0e | Product name | 2 | 20260305 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-530-15 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4833-48b1-e053-8cdaa90a720a | Proparacaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-530-15 | Proparacaine Hydrochloride | 15 mL in 1 BOTTLE, DROPPER | SOLUTION | 15 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-530-15 | ML - Milliliter | 21695-530 | 91fb8ff4-8b10-43ce-aadd-b593ae7dea7c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Proparacaine Hydrochloride | ACTIVE INGREDIENT | U96OL57GOY | PROPARACAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| Proparacaine | ACTIVE MOIETY | B4OB0JHI1X | PROPARACAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | PROPARACAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | PROPARACAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| Hydrochloric Acid | INACTIVE INGREDIENT | QTT17582CB | PROPARACAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | PROPARACAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | PROPARACAINE HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1191013 | proparacaine HCl 0.5 % Ophthalmic Solution | PSN | c1e57227-6c96-4922-973e-74838ab4c795 | 1 |
| 1191013 | proparacaine hydrochloride 5 MG/ML Ophthalmic Solution | SCD | c1e57227-6c96-4922-973e-74838ab4c795 | 1 |
| 1191013 | proparacaine hydrochloride 0.5 % Ophthalmic Solution | SY | c1e57227-6c96-4922-973e-74838ab4c795 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-530-15 | 21695053015 | 15 mL in 1 BOTTLE, DROPPER | 15 ml | Historical |