FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
72789-445
11-digit product format
727890445
Labeler code
72789
Product ID
72789-445_47a9d9a0-55c6-0d22-e063-6394a90a1518
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA208249
Marketing category
ANDA
Marketing start
2024-02-15
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208249-001AZITHROMYCINAZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A208249-001AB

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin Dihydrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui248656

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-445-02Azithromycin Dihydrate2 in 1 BOTTLE, PLASTICTABLET, FILM COATED26
72789-445-07Azithromycin Dihydrate7 in 1 BOTTLE, PLASTICTABLET, FILM COATED76
72789-445-79Azithromycin Dihydrate1 in 1 BOTTLE, PLASTICTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-445-02EA - Each72789-44503f3b67e-c65f-4278-9bf5-d2ce8f9a054d12024-12-10
72789-445-07EA - Each72789-44557fcc898-e0e4-4a8b-a87b-78135eb5fa0b12024-12-10
72789-445-79EA - Each72789-445656b60da-c8a9-45bc-89eb-48318d70daa012025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-445AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4Current NDC, 3 package rows20241212_0c926669-62b2-4ad3-8289-173c5818a9c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN0c926669-62b2-4ad3-8289-173c5818a9c16
248656azithromycin 500 MG Oral TabletSCD0c926669-62b2-4ad3-8289-173c5818a9c16
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY0c926669-62b2-4ad3-8289-173c5818a9c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-445-02727890445022 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-445-02) 2024-11-04NoNoCurrent
72789-445-07727890445077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-445-07) 2024-10-22NoNoCurrent
72789-445-79727890445791 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-445-79) 2024-12-10NoNoCurrent