FDA.reportPublic FDA data

Azithromycin

Product NDC
21695-549
11-digit product format
216950549
Labeler code
21695
Product ID
21695-549_72cd7af3-24c4-4a06-b079-ba47d07d7253
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin monohydrate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA065419
Marketing category
ANDA
Marketing start
2008-06-24
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
200 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-549-152019-09-24C16284748780-1934fe258-4773-48b1-e053-8cdaa90a720aAZITHROMYCIN FOR ORAL SUSPENSION, USP 7148 7149 Rx only
21695-549-222019-09-24C16284748780-1934fe258-4773-48b1-e053-8cdaa90a720aAZITHROMYCIN FOR ORAL SUSPENSION, USP 7148 7149 Rx only
21695-549-302019-09-24C16284748780-1934fe258-4773-48b1-e053-8cdaa90a720aAZITHROMYCIN FOR ORAL SUSPENSION, USP 7148 7149 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-549-15Azithromycin15 mL in 1 BOTTLEPOWDER, FOR SUSPENSION152
21695-549-22Azithromycin22.5 mL in 1 BOTTLEPOWDER, FOR SUSPENSION22.52
21695-549-30Azithromycin30 mL in 1 BOTTLEPOWDER, FOR SUSPENSION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-549-15ML - Milliliter21695-549c0665342-32f4-43ef-b4bd-aa58518099a012012-07-24
21695-549-22ML - Milliliter21695-549fb58d836-18f8-447e-8eff-9d27d3fd7ce412012-07-24
21695-549-30ML - Milliliter21695-54933f43628-5f3a-4031-9eed-d29b0e03d00112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
azithromycin monohydrateACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
azithromycinACTIVE MOIETYF94OW58Y8VAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
ethyl vanillinINACTIVE INGREDIENTYC9ST449YJAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATEINACTIVE INGREDIENTB70850QPHRAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
sucroseINACTIVE INGREDIENTC151H8M554AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
vanillinINACTIVE INGREDIENTCHI530446XAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-549AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.]2Legacy NDC, 3 package rows20111021_58b72e4c-f419-4a70-b894-93a5804d9993.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN58b72e4c-f419-4a70-b894-93a5804d99932
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN58b72e4c-f419-4a70-b894-93a5804d99932
308459azithromycin 20 MG/ML Oral SuspensionSCD58b72e4c-f419-4a70-b894-93a5804d99932
141963azithromycin 40 MG/ML Oral SuspensionSCD58b72e4c-f419-4a70-b894-93a5804d99932
308459azithromycin 100 MG per 5 ML Oral SuspensionSY58b72e4c-f419-4a70-b894-93a5804d99932
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY58b72e4c-f419-4a70-b894-93a5804d99932
141963azithromycin 200 MG per 5 ML Oral SuspensionSY58b72e4c-f419-4a70-b894-93a5804d99932
141963azithromycin 600 MG per 15 ML Oral SuspensionSY58b72e4c-f419-4a70-b894-93a5804d99932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-549-152169505491515 mL in 1 BOTTLE15 mlHistorical
21695-549-222169505492222.5 mL in 1 BOTTLE22.5 mlHistorical
21695-549-302169505493030 mL in 1 BOTTLE30 mlHistorical