Azithromycin

Product NDC
16571-695
11-digit product format
165710695
Labeler code
16571
Product ID
16571-695_e8114fdc-e28b-406b-bbcb-6a441de60b95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA207370
Marketing category
ANDA
Marketing start
2018-07-05
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-695-03EA - Each16571-69533edda2e-12f2-4530-a6eb-0b789a14415412020-06-05
16571-695-16EA - Each16571-69505ce54d7-c1e0-48f6-b0f6-583326a841ee12020-06-05
16571-695-81EA - Each16571-695c29e708d-e6df-43ed-abc2-63f7cb8c046312020-06-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-695-031657106950330 TABLET, FILM COATED in 1 BOTTLE (16571-695-03) 2018-07-050000-00-00NoNoCurrent
16571-695-16165710695161 BLISTER PACK in 1 CARTON (16571-695-16) > 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2018-07-050000-00-00NoNoCurrent
16571-695-81165710695813 BLISTER PACK in 1 CARTON (16571-695-81) > 6 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2018-07-050000-00-00NoNoCurrent