IOPIDINE 1%
- Product NDC
- 82667-200
- 11-digit product format
- 826670200
- Labeler code
- 82667
- Product ID
- 82667-200_515542b6-cc36-ff77-e063-6294a90ad59e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- apraclonidine hydrochloride ophthalmic solution
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Harrow Eye, LLC
- Application
- NDA019779
- Marketing category
- NDA
- Marketing start
- 2023-08-01
- Substance
- APRACLONIDINE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- IOPIDINE 1%
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| APRACLONIDINE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D2VW67N38H |
| Rxcui | 211020, 308346 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82667-200-01 | IOPIDINE 1% | 12 in 1 CARTON | SOLUTION/ DROPS | 12 | | 4 |
| 82667-200-01 | IOPIDINE 1% | 2 in 1 POUCH | SOLUTION/ DROPS | 2 | | 4 |
| 82667-200-05 | IOPIDINE 1% | 5 in 1 CARTON | SOLUTION/ DROPS | 5 | | 4 |
| 82667-200-05 | IOPIDINE 1% | 5 in 1 POUCH | SOLUTION/ DROPS | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82667-200 | IOPIDINE 1% (APRACLONIDINE HYDROCHLORIDE OPHTHALMIC SOLUTION) SOLUTION/ DROPS [HARROW EYE, LLC] | 1 | Current NDC, 4 package rows | 20230801_00f18845-ccde-8678-e063-6294a90a3374.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82667-200-01 | 82667020001 | 12 POUCH in 1 CARTON (82667-200-01) / 2 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE | 12 pouch | 2023-08-01 | No | No | Historical |
| 82667-200-05 | 82667020005 | 5 POUCH in 1 CARTON (82667-200-05) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE | 5 pouch | 2026-05-01 | No | No | Historical |