Search by Drug Name or NDC
NDC 00065-0359-05 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 00065-0359-05 (00065035905)
NDC Package Code | 0065-0359-05 |
---|---|
Billing NDC | 00065035905 |
Package | 5 mL in 1 BOTTLE, PLASTIC (0065-0359-05) |
Marketing Start Date | 1958-06-30 |
NDC Exclude Flag | N |
Pricing Information | N/A |