Cyclopentolate Hydrochloride
- Product NDC
- 61314-396
- 11-digit product format
- 613140396
- Labeler code
- 61314
- Product ID
- 61314-396_6b554ca9-699a-4d71-8e46-0130c675ca3c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclopentolate Hydrochloride
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Sandoz Inc.
- Application
- ANDA084110
- Marketing category
- ANDA
- Marketing start
- 2002-08-22
- Substance
- CYCLOPENTOLATE HYDROCHLORIDE
- Active strength
- 10 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
- Cyclopentolate Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOPENTOLATE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 736I6971TE |
| Rxcui | 1298066 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61314-396-01 | Cyclopentolate Hydrochloride | 2 mL in 1 BOTTLE | SOLUTION | 2 | | 7 |
| 61314-396-02 | Cyclopentolate Hydrochloride | 5 mL in 1 BOTTLE | SOLUTION | 5 | | 7 |
| 61314-396-03 | Cyclopentolate Hydrochloride | 15 mL in 1 BOTTLE | SOLUTION | 15 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CYCLOPENTOLATE HYDROCHLORIDE | ACTIVE INGREDIENT | 736I6971TE | CYCLOPENTOLATE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| CYCLOPENTOLATE | ACTIVE MOIETY | I76F4SHP7J | CYCLOPENTOLATE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | CYCLOPENTOLATE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | CYCLOPENTOLATE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | CYCLOPENTOLATE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | CYCLOPENTOLATE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| POTASSIUM CHLORIDE | INACTIVE INGREDIENT | 660YQ98I10 | CYCLOPENTOLATE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | CYCLOPENTOLATE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CYCLOPENTOLATE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61314-396 | CYCLOPENTOLATE HYDROCHLORIDE SOLUTION [SANDOZ INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20220626_c1b44f91-356d-4804-9509-3b457f4809e5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61314-396-01 | 61314039601 | 2 mL in 1 BOTTLE (61314-396-01) | 2 ml | 2002-08-22 | 0000-00-00 | No | No | Current |
| 61314-396-02 | 61314039602 | 5 mL in 1 BOTTLE (61314-396-02) | 5 ml | 2002-08-22 | 0000-00-00 | No | No | Current |
| 61314-396-03 | 61314039603 | 15 mL in 1 BOTTLE (61314-396-03) | 15 ml | 2002-08-22 | 0000-00-00 | No | No | Current |