Moxifloxacin
- Product NDC
- 17478-519
- 11-digit product format
- 174780519
- Labeler code
- 17478
- Product ID
- 17478-519_ac59ac51-425b-4bbd-bb9b-17950a9701b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Moxifloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA202916
- Marketing category
- ANDA
- Marketing start
- 2017-11-09
- Marketing end
- 0000-00-00
- Substance
- MOXIFLOXACIN HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC], Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|---|---|---|---|---|
| 17478-519-19 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1e3e-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use MOXIFLOXACIN OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for MOXIFLOXACIN OPHTHALMIC SOLUTION. MOXIFLOXACIN ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 1999 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17478-519-19 | Moxifloxacin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 4 | |
| 17478-519-19 | Moxifloxacin | 3 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 3 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17478-519-19 | ML - Milliliter | 17478-519 | 2352e498-78f4-4fb8-a472-bcb6228c2260 | 1 | 2017-12-14 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 403818 | moxifloxacin HCl 0.5 % Ophthalmic Solution | PSN | 7ae6355d-aaa3-48e4-a3d5-50f7ca8dfe08 | 4 |
| 403818 | moxifloxacin 5 MG/ML Ophthalmic Solution | SCD | 7ae6355d-aaa3-48e4-a3d5-50f7ca8dfe08 | 4 |
| 403818 | moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution | SY | 7ae6355d-aaa3-48e4-a3d5-50f7ca8dfe08 | 4 |
| 403818 | moxifloxacin HCl 0.5 % Ophthalmic Solution | PSN | d9b6a460-6377-76d0-e053-2995a90a3d05 | 2 |
| 403818 | moxifloxacin 5 MG/ML Ophthalmic Solution | SCD | d9b6a460-6377-76d0-e053-2995a90a3d05 | 2 |
| 403818 | moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution | SY | d9b6a460-6377-76d0-e053-2995a90a3d05 | 2 |
| 403818 | moxifloxacin HCl 0.5 % Ophthalmic Solution | PSN | ccc845e1-0a90-4c74-8659-4d798d8cf752 | 1 |
| 403818 | moxifloxacin 5 MG/ML Ophthalmic Solution | SCD | ccc845e1-0a90-4c74-8659-4d798d8cf752 | 1 |
| 403818 | moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution | SY | ccc845e1-0a90-4c74-8659-4d798d8cf752 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 17478-519-19 | 17478051919 | 1 BOTTLE, DROPPER in 1 CARTON (17478-519-19) > 3 mL in 1 BOTTLE, DROPPER | 2017-11-09 | 0000-00-00 | No | No | Current |