Cyclogyl
- Product NDC
- 0065-0395
- 11-digit product format
- 000650395
- Labeler code
- 0065
- Product ID
- 0065-0395_2fc4fc5f-9c4a-456e-9476-7791f6f9c3c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclopentolate hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alcon Laboratories, Inc.
- Application
- ANDA084109
- Marketing category
- ANDA
- Marketing start
- 1975-10-15
- Substance
- CYCLOPENTOLATE HYDROCHLORIDE
- Active strength
- 5 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cyclogyl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOPENTOLATE HYDROCHLORIDE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 736I6971TE |
| Rxcui | 1298066, 1298070, 1298072, 1298356, 1298364, 1298366 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0065-0395-15 | Cyclogyl | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 15 |
| 0065-0395-15 | Cyclogyl | 15 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 15 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CYCLOPENTOLATE HYDROCHLORIDE | ACTIVE INGREDIENT | 736I6971TE | CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| CYCLOPENTOLATE | ACTIVE MOIETY | I76F4SHP7J | CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| POTASSIUM CHLORIDE | INACTIVE INGREDIENT | 660YQ98I10 | CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0065-0395 | CYCLOGYL (CYCLOPENTOLATE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] | 15 | Current NDC, Legacy NDC, 2 package rows | 20240627_1d008c76-7210-4ace-90fa-7cd22762e12e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0065-0395-15 | 00065039515 | 1 BOTTLE, PLASTIC in 1 CARTON (0065-0395-15) / 15 mL in 1 BOTTLE, PLASTIC | 1975-10-15 | 0000-00-00 | No | No | Current |