Azithromycin Dihydrate

Product NDC
72789-066
Requested package NDC
72789-066-79
11-digit product format
727890066
Labeler code
72789
Product ID
72789-066_e61084f0-edd8-96cb-e053-2995a90a50d0
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
2019-07-01
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72789-06672789-066-79DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72789-06672789-066-79DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A208249-001AZITHROMYCINAZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25

Therapeutic equivalence codes#

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

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

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 UTC2026-02A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-253f01610625f2…
2019-09-15 20:21 UTC2019-09A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208249-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-10-25cb3db0bc1861…

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 UTC2026-02A208249-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208249-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208249-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208249-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208249-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208249-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208249-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208249-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208249-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208249-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208249-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208249-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208249-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208249-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208249-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208249-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208249-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208249-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208249-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208249-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208249-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208249-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208249-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208249-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208249-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208249-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208249-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208249-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208249-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208249-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208249-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208249-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208249-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208249-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208249-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208249-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208249-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208249-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208249-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208249-001AB1cb3db0bc1861…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-066-02EA - Each72789-0663e130749-ef01-46c2-91f7-5a22fb4fa0e512020-05-08
72789-066-03EA - Each72789-06664bd5380-8c9a-46da-acfd-bdb91611cf3712020-07-13
72789-066-07EA - Each72789-0669164e5ab-dc96-422b-8826-a93a8408283d12020-07-13
72789-066-79EA - Each72789-066d2bc9833-92a1-4fc6-962b-d1aae666e50312020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-066AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12Legacy NDC20250502_d07bb450-f0ac-4faa-8289-9d4e45bb0a88.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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azithromycin DihydrateAZITHROMYCIN DIHYDRATENuCare Pharmaceuticals,Inc.21c67de0-3a4e-caab-e063-6394a90ae3cd2026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPD-Rx Pharmaceuticals, Inc.0c926669-62b2-4ad3-8289-173c5818a9c12026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEBryant Ranch Prepack7d78cd8e-0c63-46d6-b018-939fcbbe42a62026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.7711e846-0bb3-486c-8511-f445e264cd982026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPrecision Dose, Inc.3962bc34-8236-4ac1-8ffd-2edbd430c3eb2026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.c7ed6985-1d1d-48af-9df8-64b12821789e2026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
AZITHROMYCIN DIHYDRATEAZITHROMYCIN DIHYDRATEDIRECT RXa6426d5f-5518-3c69-e053-2995a90af50f2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutionsde5b0c2b-9a7d-46e9-8169-4100442efa9b2026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATESportpharm LLC11446677-a3dc-40cb-897d-7a9851b8c89c2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPreferred Pharmaceuticals Inc.3b90572c-cc24-49f0-baaf-09022a2f9a002026-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEHealth Department, Oklahoma State4747c5d8-4831-c725-e063-6394a90a4fda2025-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATERedpharm Drug2fd1f4b5-6c32-3075-e063-6294a90a0d4b2025-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATECoupler LLC4196e616-bdd8-9e88-e063-6394a90ac81d2025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATETAGI Pharma, Inc.41e2163b-af61-4323-8b9c-2d44fc122fd92025-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEAdvanced Rx of Tennessee, LLCf1755cf3-bf7f-be40-e053-2a95a90a85362024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEProficient Rx LPbb97a057-2537-41ae-b50c-a80605039c302024-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutionsfcf098d5-dfd5-4a0d-81f7-6afa1a203a272024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutionsb4c05e22-4a54-4948-abf8-8a479d465d302024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEProficient Rx LPedecf20d-c681-418b-9c47-02fb32d2b3c02024-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutions0f36ba37-a742-41c1-ad2d-b890a1d49c552023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208249
application number: ANDA208249

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-066-79727890066791 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-066-79) 2020-03-300000-00-00NoNoCurrent