FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
68094-900
11-digit product format
680940900
Labeler code
68094
Product ID
68094-900_1200c2bd-75cb-4855-b24b-b5627726ac2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA208250
Marketing category
ANDA
Marketing start
2024-02-15
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 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 DIHYDRATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui308460, 749783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
68094-900-06Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED14
68094-900-06Azithromycin Dihydrate6 in 1 BLISTER PACKTABLET, FILM COATED64
68094-900-18Azithromycin Dihydrate3 in 1 BOXTABLET, FILM COATED34
68094-900-18Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED14
68094-900-30Azithromycin Dihydrate30 in 1 BOTTLETABLET, FILM COATED304
68094-900-50Azithromycin Dihydrate100 in 1 BOTTLETABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-900-06EA - Each68094-9001d500cad-1bf0-4785-9e3c-65a0ed56da9112024-05-16
68094-900-18EA - Each68094-90041356315-124b-46b2-bc28-f27e4ced14d712024-06-10
68094-900-30EA - Each68094-90099bd893e-0945-47ef-a29f-bb2e0000f5f412024-05-16
68094-900-50EA - Each68094-90091df9dff-c8f0-4a34-978b-53ecb4c4fd4c12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-900AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [PRECISION DOSE, INC.]1Current NDC, 6 package rows20240215_d9b66736-3f1a-4d6d-bdc4-274f5adfb40c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSNb635019e-7fd4-7f9e-e053-2a95a90a388c8
248656azithromycin 500 MG Oral TabletPSNb635019e-7fd4-7f9e-e053-2a95a90a388c8
308460azithromycin 250 MG Oral TabletSCDb635019e-7fd4-7f9e-e053-2a95a90a388c8
248656azithromycin 500 MG Oral TabletSCDb635019e-7fd4-7f9e-e053-2a95a90a388c8
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYb635019e-7fd4-7f9e-e053-2a95a90a388c8
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf0cfda1a-910f-4764-8658-263037df5ea86
308460azithromycin 250 MG Oral TabletPSNf0cfda1a-910f-4764-8658-263037df5ea86
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf0cfda1a-910f-4764-8658-263037df5ea86
308460azithromycin 250 MG Oral TabletSCDf0cfda1a-910f-4764-8658-263037df5ea86
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf0cfda1a-910f-4764-8658-263037df5ea86
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK2065c4ba-e3f5-41a2-b3d5-205dab6469244
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKd9b66736-3f1a-4d6d-bdc4-274f5adfb40c4
308460azithromycin 250 MG Oral TabletPSNd9b66736-3f1a-4d6d-bdc4-274f5adfb40c4
308460azithromycin 250 MG Oral TabletPSN7ab854bf-eb04-42c4-a403-096b60581bb44
308460azithromycin 250 MG Oral TabletPSN2065c4ba-e3f5-41a2-b3d5-205dab6469244
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNd9b66736-3f1a-4d6d-bdc4-274f5adfb40c4
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN2065c4ba-e3f5-41a2-b3d5-205dab6469244
308460azithromycin 250 MG Oral TabletSCDd9b66736-3f1a-4d6d-bdc4-274f5adfb40c4
308460azithromycin 250 MG Oral TabletSCD2065c4ba-e3f5-41a2-b3d5-205dab6469244
308460azithromycin 250 MG Oral TabletSCD7ab854bf-eb04-42c4-a403-096b60581bb44
749783azithromycin 250 MG Oral Tablet 6 Count PackSY2065c4ba-e3f5-41a2-b3d5-205dab6469244
749783azithromycin 250 MG Oral Tablet 6 Count PackSYd9b66736-3f1a-4d6d-bdc4-274f5adfb40c4
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKb3c84aea-7ba7-4aae-999c-db740a9e53df2
308460azithromycin 250 MG Oral TabletPSNb3c84aea-7ba7-4aae-999c-db740a9e53df2
308460azithromycin 250 MG Oral TabletPSN258dd3c5-dce9-7483-e063-6294a90a40432
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNb3c84aea-7ba7-4aae-999c-db740a9e53df2
308460azithromycin 250 MG Oral TabletSCDb3c84aea-7ba7-4aae-999c-db740a9e53df2
308460azithromycin 250 MG Oral TabletSCD258dd3c5-dce9-7483-e063-6294a90a40432
749783azithromycin 250 MG Oral Tablet 6 Count PackSYb3c84aea-7ba7-4aae-999c-db740a9e53df2
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKa8e106cb-7245-45a5-9aad-bd624b1e011d1
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK44f52ce0-ad3f-7d80-e063-6294a90ad0861
308460azithromycin 250 MG Oral TabletPSN44f52ce0-ad3f-7d80-e063-6294a90ad0861
308460azithromycin 250 MG Oral TabletPSN2cc99fae-a72c-8893-e063-6394a90aa3ef1
308460azithromycin 250 MG Oral TabletPSNa8e106cb-7245-45a5-9aad-bd624b1e011d1
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN44f52ce0-ad3f-7d80-e063-6294a90ad0861
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNa8e106cb-7245-45a5-9aad-bd624b1e011d1
308460azithromycin 250 MG Oral TabletSCD44f52ce0-ad3f-7d80-e063-6294a90ad0861
308460azithromycin 250 MG Oral TabletSCD2cc99fae-a72c-8893-e063-6394a90aa3ef1
308460azithromycin 250 MG Oral TabletSCDa8e106cb-7245-45a5-9aad-bd624b1e011d1
749783azithromycin 250 MG Oral Tablet 6 Count PackSY44f52ce0-ad3f-7d80-e063-6294a90ad0861
749783azithromycin 250 MG Oral Tablet 6 Count PackSYa8e106cb-7245-45a5-9aad-bd624b1e011d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68094-900-06680940900061 BLISTER PACK in 1 CARTON (68094-900-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2024-02-15NoNoCurrent
68094-900-18680940900183 CARTON in 1 BOX (68094-900-18) / 1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK3 carton2024-02-15NoNoCurrent
68094-900-306809409003030 TABLET, FILM COATED in 1 BOTTLE (68094-900-30) 2024-02-15NoNoCurrent
68094-900-5068094090050100 TABLET, FILM COATED in 1 BOTTLE (68094-900-50) 2024-02-15NoNoCurrent