Azithromycin Dihydrate

Product NDC
68788-8101
11-digit product format
687888101
Labeler code
68788
Product ID
68788-8101_1ad4ced9-291d-42e2-ac28-87ac2262bd02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208250
Marketing category
ANDA
Marketing start
2021-10-08
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-8101DDiscontinued by firm2026-08-03
excluded packagepackage68788-810168788-8101-6DDiscontinued 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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-8101-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-8101-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-8101-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-8101-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-8101-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-8101-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-8101-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-8101-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-8101-60efc9e666f02…f202fb6c5f17…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8101-6EA - Each68788-8101b0f349d2-aa75-40d5-a124-cd4c0bbe3f0b12021-12-08

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8101-6687888101061 BLISTER PACK in 1 CARTON (68788-8101-6) > 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-10-080000-00-00NoNoCurrent