FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
68094-799
11-digit product format
680940799
Labeler code
68094
Product ID
68094-799_30012db7-75f6-47ef-838b-301c9a3b2c8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Precision Dose, 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

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, 749780

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
68094-799-03Azithromycin Dihydrate3 in 1 BLISTER PACKTABLET, FILM COATED34
68094-799-03Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED14
68094-799-09Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED14
68094-799-09Azithromycin Dihydrate3 in 1 BOXTABLET, FILM COATED34
68094-799-30Azithromycin Dihydrate30 in 1 BOTTLETABLET, FILM COATED304
68094-799-50Azithromycin Dihydrate100 in 1 BOTTLETABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-799-03EA - Each68094-799795a6796-c181-4acc-8e5c-45bf7c81d62112024-05-16
68094-799-09EA - Each68094-799d2e34b34-b459-436f-a6d2-8e07a8c5455a12024-08-12
68094-799-30EA - Each68094-799ae9aa040-e9b1-4797-99b8-4de8c2d30b2e12024-05-16
68094-799-50EA - Each68094-7991de7d5cb-d560-48e0-976d-1a04098f2e1812024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-799AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [PRECISION DOSE, INC.]1Current NDC, 6 package rows20240215_3962bc34-8236-4ac1-8ffd-2edbd430c3eb.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
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK2fd1f4b5-6c32-3075-e063-6294a90a0d4b5
248656azithromycin 500 MG Oral TabletPSN2fd1f4b5-6c32-3075-e063-6294a90a0d4b5
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN2fd1f4b5-6c32-3075-e063-6294a90a0d4b5
248656azithromycin 500 MG Oral TabletSCD2fd1f4b5-6c32-3075-e063-6294a90a0d4b5
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY2fd1f4b5-6c32-3075-e063-6294a90a0d4b5
749780azithromycin 500 MG Oral Tablet 3 Count PackSY2fd1f4b5-6c32-3075-e063-6294a90a0d4b5
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK3962bc34-8236-4ac1-8ffd-2edbd430c3eb4
248656azithromycin 500 MG Oral TabletPSN3962bc34-8236-4ac1-8ffd-2edbd430c3eb4
248656azithromycin 500 MG Oral TabletPSNde5b0c2b-9a7d-46e9-8169-4100442efa9b4
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN3962bc34-8236-4ac1-8ffd-2edbd430c3eb4
248656azithromycin 500 MG Oral TabletSCDde5b0c2b-9a7d-46e9-8169-4100442efa9b4
248656azithromycin 500 MG Oral TabletSCD3962bc34-8236-4ac1-8ffd-2edbd430c3eb4
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYde5b0c2b-9a7d-46e9-8169-4100442efa9b4
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY3962bc34-8236-4ac1-8ffd-2edbd430c3eb4
749780azithromycin 500 MG Oral Tablet 3 Count PackSY3962bc34-8236-4ac1-8ffd-2edbd430c3eb4
248656azithromycin 500 MG Oral TabletPSN7711e846-0bb3-486c-8511-f445e264cd983
248656azithromycin 500 MG Oral TabletSCD7711e846-0bb3-486c-8511-f445e264cd983
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY7711e846-0bb3-486c-8511-f445e264cd983
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK11446677-a3dc-40cb-897d-7a9851b8c89c2
248656azithromycin 500 MG Oral TabletPSN11446677-a3dc-40cb-897d-7a9851b8c89c2
248656azithromycin 500 MG Oral TabletPSN3b90572c-cc24-49f0-baaf-09022a2f9a002
248656azithromycin 500 MG Oral TabletPSN21c67de0-3a4e-caab-e063-6394a90ae3cd2
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN11446677-a3dc-40cb-897d-7a9851b8c89c2
248656azithromycin 500 MG Oral TabletSCD3b90572c-cc24-49f0-baaf-09022a2f9a002
248656azithromycin 500 MG Oral TabletSCD21c67de0-3a4e-caab-e063-6394a90ae3cd2
248656azithromycin 500 MG Oral TabletSCD11446677-a3dc-40cb-897d-7a9851b8c89c2
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY3b90572c-cc24-49f0-baaf-09022a2f9a002
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY21c67de0-3a4e-caab-e063-6394a90ae3cd2
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY11446677-a3dc-40cb-897d-7a9851b8c89c2
749780azithromycin 500 MG Oral Tablet 3 Count PackSY11446677-a3dc-40cb-897d-7a9851b8c89c2
248656azithromycin 500 MG Oral TabletPSN4196e616-bdd8-9e88-e063-6394a90ac81d1
248656azithromycin 500 MG Oral TabletPSN4747c5d8-4831-c725-e063-6394a90a4fda1
248656azithromycin 500 MG Oral TabletPSNedecf20d-c681-418b-9c47-02fb32d2b3c01
248656azithromycin 500 MG Oral TabletPSNfcf098d5-dfd5-4a0d-81f7-6afa1a203a271
248656azithromycin 500 MG Oral TabletPSN7d78cd8e-0c63-46d6-b018-939fcbbe42a61
248656azithromycin 500 MG Oral TabletPSNb4c05e22-4a54-4948-abf8-8a479d465d301
248656azithromycin 500 MG Oral TabletSCD7d78cd8e-0c63-46d6-b018-939fcbbe42a61
248656azithromycin 500 MG Oral TabletSCDedecf20d-c681-418b-9c47-02fb32d2b3c01
248656azithromycin 500 MG Oral TabletSCDb4c05e22-4a54-4948-abf8-8a479d465d301
248656azithromycin 500 MG Oral TabletSCDfcf098d5-dfd5-4a0d-81f7-6afa1a203a271
248656azithromycin 500 MG Oral TabletSCD4747c5d8-4831-c725-e063-6394a90a4fda1
248656azithromycin 500 MG Oral TabletSCD4196e616-bdd8-9e88-e063-6394a90ac81d1
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYedecf20d-c681-418b-9c47-02fb32d2b3c01
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYfcf098d5-dfd5-4a0d-81f7-6afa1a203a271
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYb4c05e22-4a54-4948-abf8-8a479d465d301
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY7d78cd8e-0c63-46d6-b018-939fcbbe42a61
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY4747c5d8-4831-c725-e063-6394a90a4fda1
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY4196e616-bdd8-9e88-e063-6394a90ac81d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68094-799-03680940799031 BLISTER PACK in 1 CARTON (68094-799-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2024-02-15NoNoCurrent
68094-799-09680940799093 CARTON in 1 BOX (68094-799-09) / 1 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK3 carton2024-02-15NoNoCurrent
68094-799-306809407993030 TABLET, FILM COATED in 1 BOTTLE (68094-799-30) 2024-02-15NoNoCurrent
68094-799-5068094079950100 TABLET, FILM COATED in 1 BOTTLE (68094-799-50) 2024-02-15NoNoCurrent