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NDC 00065-0359-02 Cyclomydril 2; 10 mg/mL; mg/mL Details
Cyclomydril 2; 10 mg/mL; mg/mL
Cyclomydril is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE.
Product Information
| NDC | 00065-0359 |
|---|---|
| Product ID | 0065-0359_6470e4d3-4917-416e-a6e6-3b2574b041a7 |
| Associated GPIs | 86359902102010 |
| GCN Sequence Number | 048541 |
| GCN Sequence Number Description | cyclopentolate/phenylephrine DROPS 0.2 %-1 % OPHTHALMIC |
| HIC3 | Q6J |
| HIC3 Description | MYDRIATICS |
| GCN | 14277 |
| HICL Sequence Number | 003473 |
| HICL Sequence Number Description | CYCLOPENTOLATE HCL/PHENYLEPHRINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Cyclomydril |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | cyclopentolate hydrochloride and phenylephrine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 2; 10 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Alcon Laboratories, Inc. |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA084300 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00065-0359-02 (00065035902)
| NDC Package Code | 0065-0359-02 |
|---|---|
| Billing NDC | 00065035902 |
| Package | 2 mL in 1 BOTTLE, PLASTIC (0065-0359-02) |
| Marketing Start Date | 1958-06-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |