FDA.reportPublic FDA data

Avelox

Product NDC
0085-1733
11-digit product format
000851733
Labeler code
0085
Product ID
0085-1733_9ae0561c-5e62-425f-a7f3-5cdbb842de80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
moxifloxacin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Schering Plough Corporation
Application
NDA021085
Marketing category
NDA
Marketing start
1999-12-10
Marketing end
0000-00-00
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
84b851da-be59-d750-14d1-e4d93cc3b4daProduct name920250630
2194a6ab-15bb-de49-cced-f09e642b1b64Product name820240313
d7840f4c-f22a-4403-b5da-53ac6ac8fd90Product name120150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531bProduct name220150611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0085-1733-01EA - Each0085-173361115809-0afc-4295-b978-716ed2e19d2512012-07-24
0085-1733-02EA - Each0085-1733f47ee6c5-f696-428f-ba3f-28476fecf63b12012-07-24
0085-1733-03EA - Each0085-17337988914a-1d33-4d2b-8876-3b7467cd67a212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MOXIFLOXACIN HYDROCHLORIDEACTIVE INGREDIENTC53598599TAVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
MOXIFLOXACINACTIVE MOIETYU188XYD42PAVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]6
MOXIFLOXACIN HYDROCHLORIDEACTIVE INGREDIENTC53598599TAVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]2
MOXIFLOXACINACTIVE MOIETYU188XYD42PAVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REDPHARM DRUG INC.]2
MOXIFLOXACIN HYDROCHLORIDEACTIVE INGREDIENTC53598599TAVELOX ABC PACK (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]1
MOXIFLOXACINACTIVE MOIETYU188XYD42PAVELOX ABC PACK (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
261339Avelox 400 MG Oral TabletPSN222e661d-e956-441a-a02b-b70e0f05c3286
311787moxifloxacin HCl 400 MG Oral TabletPSN222e661d-e956-441a-a02b-b70e0f05c3286
261339moxifloxacin 400 MG Oral Tablet [Avelox]SBD222e661d-e956-441a-a02b-b70e0f05c3286
311787moxifloxacin 400 MG Oral TabletSCD222e661d-e956-441a-a02b-b70e0f05c3286
261339Avelox 400 MG Oral TabletSY222e661d-e956-441a-a02b-b70e0f05c3286
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY222e661d-e956-441a-a02b-b70e0f05c3286
261339Avelox 400 MG Oral TabletPSNfe9226f8-64f4-4eff-8339-ed3fce0896f22
311787moxifloxacin HCl 400 MG Oral TabletPSNfe9226f8-64f4-4eff-8339-ed3fce0896f22
261339moxifloxacin 400 MG Oral Tablet [Avelox]SBDfe9226f8-64f4-4eff-8339-ed3fce0896f22
311787moxifloxacin 400 MG Oral TabletSCDfe9226f8-64f4-4eff-8339-ed3fce0896f22
261339Avelox 400 MG Oral TabletSYfe9226f8-64f4-4eff-8339-ed3fce0896f22
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSYfe9226f8-64f4-4eff-8339-ed3fce0896f22
261339Avelox 400 MG Oral TabletPSN7d74dfa6-0468-43ad-ad7f-dd90d9ae77061
311787moxifloxacin HCl 400 MG Oral TabletPSN7d74dfa6-0468-43ad-ad7f-dd90d9ae77061
261339moxifloxacin 400 MG Oral Tablet [Avelox]SBD7d74dfa6-0468-43ad-ad7f-dd90d9ae77061
311787moxifloxacin 400 MG Oral TabletSCD7d74dfa6-0468-43ad-ad7f-dd90d9ae77061
261339Avelox 400 MG Oral TabletSY7d74dfa6-0468-43ad-ad7f-dd90d9ae77061
311787moxifloxacin (as moxifloxacin HCl) 400 MG Oral TabletSY7d74dfa6-0468-43ad-ad7f-dd90d9ae77061