Mydriacyl
- Product NDC
- 0998-0355
- 11-digit product format
- 009980355
- Labeler code
- 0998
- Product ID
- 0998-0355_86af6085-d52b-4516-8234-64ae8baa98b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tropicamide
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alcon Laboratories, Inc.
- Application
- ANDA084306
- Marketing category
- ANDA
- Marketing start
- 1959-04-01
- Substance
- TROPICAMIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mydriacyl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TROPICAMIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N0A3Z5XTC6 |
| Rxcui | 208660, 314238 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0998-0355-15 | Mydriacyl | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | | 9 |
| 0998-0355-15 | Mydriacyl | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TROPICAMIDE | ACTIVE INGREDIENT | N0A3Z5XTC6 | MYDRIACYL (TROPICAMIDE) SOLUTION [ALCON LABORATORIES, INC.] | 1 | |
| TROPICAMIDE | ACTIVE MOIETY | N0A3Z5XTC6 | MYDRIACYL (TROPICAMIDE) SOLUTION [ALCON LABORATORIES, INC.] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | MYDRIACYL (TROPICAMIDE) SOLUTION [ALCON LABORATORIES, INC.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | MYDRIACYL (TROPICAMIDE) SOLUTION [ALCON LABORATORIES, INC.] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | MYDRIACYL (TROPICAMIDE) SOLUTION [ALCON LABORATORIES, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | MYDRIACYL (TROPICAMIDE) SOLUTION [ALCON LABORATORIES, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | MYDRIACYL (TROPICAMIDE) SOLUTION [ALCON LABORATORIES, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | MYDRIACYL (TROPICAMIDE) SOLUTION [ALCON LABORATORIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0998-0355 | MYDRIACYL (TROPICAMIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20230217_0d4f4a2e-eb00-4c65-b3fa-baf5738d468d.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 |
|---|
| 0998-0355-15 | 00998035515 | 1 BOTTLE in 1 CARTON (0998-0355-15) / 15 mL in 1 BOTTLE | 1 bottle | 1959-04-01 | 0000-00-00 | No | No | Current |