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NDC 00998-0355-15 Mydriacyl 10 mg/mL Details
Mydriacyl 10 mg/mL
Mydriacyl is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is TROPICAMIDE.
Product Information
| NDC | 00998-0355 |
|---|---|
| Product ID | 0998-0355_86af6085-d52b-4516-8234-64ae8baa98b4 |
| Associated GPIs | 86350050002010 |
| GCN Sequence Number | 007873 |
| GCN Sequence Number Description | tropicamide DROPS 1 % OPHTHALMIC |
| HIC3 | Q6J |
| HIC3 Description | MYDRIATICS |
| GCN | 33021 |
| HICL Sequence Number | 003466 |
| HICL Sequence Number Description | TROPICAMIDE |
| Brand/Generic | Brand |
| Proprietary Name | Mydriacyl |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | tropicamide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | TROPICAMIDE |
| Labeler Name | Alcon Laboratories, Inc. |
| Pharmaceutical Class | Anticholinergic [EPC], Cholinergic Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA084306 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00998-0355-15 (00998035515)
| NDC Package Code | 0998-0355-15 |
|---|---|
| Billing NDC | 00998035515 |
| Package | 1 BOTTLE in 1 CARTON (0998-0355-15) / 15 mL in 1 BOTTLE |
| Marketing Start Date | 1959-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |