Cyclopentolate Hydrochloride is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc.. The primary component is Cyclopentolate Hydrochloride.
| Product ID | 61314-396_045e8129-2a07-1cfc-2d85-05ce7e8df314 |
| NDC | 61314-396 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Cyclopentolate Hydrochloride |
| Generic Name | Cyclopentolate Hydrochloride |
| Dosage Form | Solution |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 2002-08-22 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA084110 |
| Labeler Name | Sandoz Inc. |
| Substance Name | CYCLOPENTOLATE HYDROCHLORIDE |
| Active Ingredient Strength | 10 mg/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2002-08-22 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA084110 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-08-22 |
| Marketing Category | ANDA |
| Application Number | ANDA084110 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2002-08-22 |
| Marketing Category | ANDA |
| Application Number | ANDA084110 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-08-22 |
| Ingredient | Strength |
|---|---|
| CYCLOPENTOLATE HYDROCHLORIDE | 10 mg/mL |
| SPL SET ID: | c1b44f91-356d-4804-9509-3b457f4809e5 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 17478-097 | Cyclopentolate Hydrochloride | Cyclopentolate Hydrochloride |
| 17478-100 | Cyclopentolate Hydrochloride | Cyclopentolate Hydrochloride |
| 24208-735 | Cyclopentolate Hydrochloride | Cyclopentolate Hydrochloride |
| 42254-013 | Cyclopentolate Hydrochloride | Cyclopentolate Hydrochloride |
| 50090-3234 | Cyclopentolate Hydrochloride | Cyclopentolate Hydrochloride |
| 50090-3874 | Cyclopentolate Hydrochloride | Cyclopentolate Hydrochloride |
| 61314-396 | Cyclopentolate Hydrochloride | Cyclopentolate Hydrochloride |
| 21695-883 | AK-PENTOLATE | Cyclopentolate Hydrochloride |
| 0065-0395 | Cyclogyl | cyclopentolate hydrochloride |
| 0065-0396 | Cyclogyl | cyclopentolate hydrochloride |
| 0065-0397 | Cyclogyl | cyclopentolate hydrochloride |
| 17478-096 | Cyclopentolate | Cyclopentolate Hydrochloride |