Xalatan
- Product NDC
- 68258-8976
- 11-digit product format
- 682588976
- Labeler code
- 68258
- Product ID
- 68258-8976_309e27fc-3503-4307-880c-2d9492423870
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- latanoprost
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Dispensing Solutions, Inc.
- Application
- NDA020597
- Marketing category
- NDA
- Marketing start
- 1995-03-20
- Marketing end
- 0000-00-00
- Substance
- LATANOPROST
- Active strength
- 50 ug/mL
- Pharmacologic classes
- Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68258-8976-2 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b80d-f6ea-e053-dbdaa90aa703 | Xalatan ® latanoprost ophthalmic solution 0.005% (50 µg/mL) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68258-8976-2 | Xalatan | 2.5 mL in 1 BOTTLE, DROPPER | SOLUTION | 2.5 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| latanoprost | ACTIVE INGREDIENT | 6Z5B6HVF6O | XALATAN (LATANOPROST) SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| latanoprost | ACTIVE MOIETY | 6Z5B6HVF6O | XALATAN (LATANOPROST) SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| Benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | XALATAN (LATANOPROST) SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | XALATAN (LATANOPROST) SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| sodium phosphate, dibasic anhydrous | INACTIVE INGREDIENT | 22ADO53M6F | XALATAN (LATANOPROST) SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | XALATAN (LATANOPROST) SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68258-8976 | XALATAN (LATANOPROST) SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 1 package rows | 20111007_0f4881ec-2984-4853-bc25-5b14c3b79da7.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314072 | latanoprost 0.005 % Ophthalmic Solution | PSN | 0f4881ec-2984-4853-bc25-5b14c3b79da7 | 1 |
| 542527 | Xalatan 0.005 % Ophthalmic Solution | PSN | 0f4881ec-2984-4853-bc25-5b14c3b79da7 | 1 |
| 542527 | latanoprost 0.05 MG/ML Ophthalmic Solution [Xalatan] | SBD | 0f4881ec-2984-4853-bc25-5b14c3b79da7 | 1 |
| 314072 | latanoprost 0.05 MG/ML Ophthalmic Solution | SCD | 0f4881ec-2984-4853-bc25-5b14c3b79da7 | 1 |
| 314072 | latanoprost 0.005 % Ophthalmic Solution | SY | 0f4881ec-2984-4853-bc25-5b14c3b79da7 | 1 |
| 314072 | latanoprost 125 MCG per 2.5 ML Ophthalmic Solution | SY | 0f4881ec-2984-4853-bc25-5b14c3b79da7 | 1 |
| 542527 | Xalatan 0.005 % Ophthalmic Solution | SY | 0f4881ec-2984-4853-bc25-5b14c3b79da7 | 1 |
| 542527 | Xalatan 125 MCG per 2.5 ML Ophthalmic Solution | SY | 0f4881ec-2984-4853-bc25-5b14c3b79da7 | 1 |
| 542527 | Xalatan 50 MCG/ML Ophthalmic Solution | SY | 0f4881ec-2984-4853-bc25-5b14c3b79da7 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 68258-8976-2 | 68258897602 | 2.5 mL in 1 BOTTLE, DROPPER | 2.5 ml | Historical |