Apraclonidine
- Product NDC
- 61314-665
- 11-digit product format
- 613140665
- Labeler code
- 61314
- Product ID
- 61314-665_238af96f-2f89-9af4-e063-6394a90a9516
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Apraclonidine
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Sandoz Inc
- Application
- NDA020258
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2009-07-19
- Substance
- APRACLONIDINE HYDROCHLORIDE
- Active strength
- 5.75 mg/mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Apraclonidine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| APRACLONIDINE HYDROCHLORIDE | 5.75 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D2VW67N38H |
| Rxcui | 308345 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61314-665-05 | Apraclonidine | 5 mL in 1 BOTTLE | SOLUTION | 5 | | 8 |
| 61314-665-10 | Apraclonidine | 10 mL in 1 BOTTLE | SOLUTION | 10 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| APRACLONIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | D2VW67N38H | APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 5 | |
| APRACLONIDINE | ACTIVE MOIETY | 843CEN85DI | APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 5 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 5 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 5 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 5 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 5 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | APRACLONIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61314-665 | APRACLONIDINE SOLUTION [SANDOZ INC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241009_04ad82af-e7ba-4f40-a120-be9d33cf0c7b.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 |
|---|
| 61314-665-05 | 61314066505 | 5 mL in 1 BOTTLE (61314-665-05) | 5 ml | 2009-07-19 | 0000-00-00 | No | No | Current |
| 61314-665-10 | 61314066510 | 10 mL in 1 BOTTLE (61314-665-10) | 10 ml | 2009-07-19 | 0000-00-00 | No | No | Current |