AZITHROMYCIN DIHYDRATE

Product NDC
72189-089
11-digit product format
721890089
Labeler code
72189
Product ID
72189-089_4d3a98e6-31e9-c271-e063-6394a90aa19e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN DIHYDRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA208250
Marketing category
ANDA
Marketing start
2020-10-15
Marketing end
2026-10-31
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208250-001AZITHROMYCINAZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A208250-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-173f01610625f2…
2019-09-15 20:21 UTC2019-09A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208250-001AZITHROMYCINEQ 250MG BASETABLET / ORALAB2019-04-17cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208250-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208250-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208250-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208250-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208250-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208250-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208250-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208250-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208250-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208250-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208250-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208250-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208250-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208250-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208250-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208250-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208250-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208250-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208250-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208250-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208250-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208250-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208250-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208250-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208250-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208250-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208250-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208250-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208250-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208250-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208250-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208250-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208250-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208250-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208250-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208250-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208250-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208250-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208250-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208250-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
AZITHROMYCIN DIHYDRATE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5FD1131I7SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
248656Internal RxNorm lookup
308460Internal RxNorm lookup
749780Internal RxNorm lookup
749783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a5b4092d-ab72-f5d1-e053-2995a90ac582Available on FDA.report

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
72189-089-06AZITHROMYCIN DIHYDRATE6 in 1 BOTTLETABLET, FILM COATED67

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-089-06EA - Each72189-089d2a6c3f0-7cd1-4c8f-b401-332140ee874012021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-089AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [DIRECT RX]6Current NDC, Legacy NDC, 1 package rows20241116_a5b4092d-ab72-f5d1-e053-2995a90ac582.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPD-Rx Pharmaceuticals, Inc.7ab854bf-eb04-42c4-a403-096b60581bb42026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPrecision Dose, Inc.d9b66736-3f1a-4d6d-bdc4-274f5adfb40c2026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
AZITHROMYCINAZITHROMYCINDIRECT RXa5b4092d-ab72-f5d1-e053-2995a90ac5822026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
ndc (product): 72189-089
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.f0cfda1a-910f-4764-8658-263037df5ea82026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPreferred Pharmaceuticals Inc.b3c84aea-7ba7-4aae-999c-db740a9e53df2026-01-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEAvPAKb635019e-7fd4-7f9e-e053-2a95a90a388c2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATERedpharm Drug44f52ce0-ad3f-7d80-e063-6294a90ad0862025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutionsdf9b39b7-d42d-4c4b-b492-9fd228978dec2025-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPD-Rx Pharmaceuticals, Inc.e9800bbe-e8bf-4689-a8a5-dc23b5d2ee562025-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATETAGI Pharma, Inc.9f0501bf-d1c4-46a5-b253-3b9e61015e822025-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATECoupler LLC2cc99fae-a72c-8893-e063-6394a90aa3ef2025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEProficient Rx LPa8e106cb-7245-45a5-9aad-bd624b1e011d2025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEAdvanced Rx Pharmacy of Tennessee, LLCf1752913-85ac-01fa-e053-2995a90a2bd82024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATENuCare Pharmaceuticals Inc.258dd3c5-dce9-7483-e063-6294a90a40432024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEQuality Care Products, LLC2065c4ba-e3f5-41a2-b3d5-205dab6469242024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutions1c84a68b-3eaa-4dab-b5e5-e195c7652e672024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEProficient Rx LP8037c6f4-4881-4740-8229-2aee56141cd02022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEAsclemed USA, Inc.b08bd8fc-20da-4623-9211-ae669452b16d2020-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208250
application number: ANDA208250

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKa5b4092d-ab72-f5d1-e053-2995a90ac5827
308460azithromycin 250 MG Oral TabletPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG Oral TabletPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNa5b4092d-ab72-f5d1-e053-2995a90ac5827
308460azithromycin 250 MG Oral TabletSCDa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG Oral TabletSCDa5b4092d-ab72-f5d1-e053-2995a90ac5827
749783azithromycin 250 MG Oral Tablet 6 Count PackSYa5b4092d-ab72-f5d1-e053-2995a90ac5827
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYa5b4092d-ab72-f5d1-e053-2995a90ac5827
749780azithromycin 500 MG Oral Tablet 3 Count PackSYa5b4092d-ab72-f5d1-e053-2995a90ac5827

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-089-06721890089066 TABLET, FILM COATED in 1 BOTTLE (72189-089-06) 2020-10-152026-10-31NoNoCurrent