MOXIFLOXACIN HYDROCHLORIDE
- Product NDC
- 65862-603
- 11-digit product format
- 658620603
- Labeler code
- 65862
- Product ID
- 65862-603_412cb5bf-66ad-4815-bf15-8d225c09260b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- moxifloxacin hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202632
- Marketing category
- ANDA
- Marketing start
- 2014-03-04
- Substance
- MOXIFLOXACIN HYDROCHLORIDE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MOXIFLOXACIN HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MOXIFLOXACIN HYDROCHLORIDE | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C53598599T |
| Rxcui | 311787 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-603-10 | MOXIFLOXACIN HYDROCHLORIDE | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 17 |
| 65862-603-30 | MOXIFLOXACIN HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 17 |
| 65862-603-55 | MOXIFLOXACIN HYDROCHLORIDE | 50 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 50 | | 17 |
| 65862-603-99 | MOXIFLOXACIN HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MOXIFLOXACIN HYDROCHLORIDE | ACTIVE INGREDIENT | C53598599T | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| MOXIFLOXACIN | ACTIVE MOIETY | U188XYD42P | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | |
| MOXIFLOXACIN HYDROCHLORIDE | ACTIVE INGREDIENT | C53598599T | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| MOXIFLOXACIN | ACTIVE MOIETY | U188XYD42P | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-603 | MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 16 | Current NDC, Legacy NDC, 4 package rows | 20241213_d6789c17-4a2f-4519-9060-e3b0dba422f0.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 |
|---|
| 65862-603-10 | 65862060310 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 65862-603-30 | 65862060330 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-603-30) | | 2014-03-04 | 0000-00-00 | No | No | Current |
| 65862-603-55 | 65862060355 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (65862-603-55) / 1 TABLET, FILM COATED in 1 BLISTER PACK (65862-603-10) | 50 blister pack | 2014-03-04 | 0000-00-00 | No | No | Current |
| 65862-603-99 | 65862060399 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-603-99) | | 2014-03-04 | 0000-00-00 | No | No | Current |