VIGAMOX
- Product NDC
- 21695-968
- 11-digit product format
- 216950968
- Labeler code
- 21695
- Product ID
- 21695-968_68cca7e1-120c-4ac6-8851-15a17e11bd9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- moxifloxacin hydrochloride
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Rebel Distributors Corp
- Application
- NDA021598
- Marketing category
- NDA
- Marketing start
- 2003-05-07
- Marketing end
- 0000-00-00
- Substance
- MOXIFLOXACIN HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC],Quinolones [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 84b851da-be59-d750-14d1-e4d93cc3b4da | Product name | 9 | 20250630 |
| 2194a6ab-15bb-de49-cced-f09e642b1b64 | Product name | 8 | 20240313 |
| d7840f4c-f22a-4403-b5da-53ac6ac8fd90 | Product name | 1 | 20150728 |
| ccc7bb05-654a-45d2-a0d6-09ab96ba531b | Product name | 2 | 20150611 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-968-03 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4971-48b1-e053-8cdaa90a720a | VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5% as base |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-968-03 | VIGAMOX | 3 mL in 1 BOTTLE, PLASTIC | SOLUTION | 3 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-968-03 | ML - Milliliter | 21695-968 | ddb6a236-b949-4daa-93f1-8e6ffe32a390 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MOXIFLOXACIN HYDROCHLORIDE | ACTIVE INGREDIENT | C53598599T | VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| MOXIFLOXACIN | ACTIVE MOIETY | U188XYD42P | VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 403818 | moxifloxacin HCl 0.5 % Ophthalmic Solution | PSN | 68cca7e1-120c-4ac6-8851-15a17e11bd9f | 1 |
| 404473 | VIGAMOX 0.5 % Ophthalmic Solution | PSN | 68cca7e1-120c-4ac6-8851-15a17e11bd9f | 1 |
| 404473 | moxifloxacin 5 MG/ML Ophthalmic Solution [Vigamox] | SBD | 68cca7e1-120c-4ac6-8851-15a17e11bd9f | 1 |
| 403818 | moxifloxacin 5 MG/ML Ophthalmic Solution | SCD | 68cca7e1-120c-4ac6-8851-15a17e11bd9f | 1 |
| 403818 | moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution | SY | 68cca7e1-120c-4ac6-8851-15a17e11bd9f | 1 |
| 404473 | Vigamox 0.5 % Ophthalmic Solution | SY | 68cca7e1-120c-4ac6-8851-15a17e11bd9f | 1 |
| 404473 | Vigamox 5 MG/ML Ophthalmic Solution | SY | 68cca7e1-120c-4ac6-8851-15a17e11bd9f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-968-03 | 21695096803 | 3 mL in 1 BOTTLE, PLASTIC | 3 ml | Historical |