Azithromycin

Product NDC
51672-4200
11-digit product format
516724200
Labeler code
51672
Product ID
51672-4200_30b09990-10ca-4452-920b-c1d1dc830120
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN MONOHYDRATE
Dosage form
SUSPENSION
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA211521
Marketing category
ANDA
Marketing start
2019-12-11
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
200 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4200-3ML - Milliliter51672-4200eacb43e2-4e6e-43a7-8ded-e8731880a30912021-09-07
51672-4200-5ML - Milliliter51672-42004f340a47-7d0c-461a-bbd4-1a293a0b3d4912021-09-07
51672-4200-7ML - Milliliter51672-42006cd24f35-e5fb-4e88-b268-751b5eb709b112021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4200AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5Legacy NDC20241222_071e71b8-bb53-4075-9bda-2ec48affa018.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4200-3516724200031 BOTTLE in 1 CARTON (51672-4200-3) > 30 mL in 1 BOTTLE1 bottle2019-12-110000-00-00NoNoCurrent
51672-4200-5516724200051 BOTTLE in 1 CARTON (51672-4200-5) > 15 mL in 1 BOTTLE1 bottle2019-12-110000-00-00NoNoCurrent
51672-4200-7516724200071 BOTTLE in 1 CARTON (51672-4200-7) > 22.5 mL in 1 BOTTLE1 bottle2019-12-110000-00-00NoNoCurrent