Azithromycin Dihydrate

Product NDC
80425-0220
11-digit product format
804250220
Labeler code
80425
Product ID
80425-0220_2a9ae6d7-0498-3bd5-e063-6394a90a651e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA208249
Marketing category
ANDA
Marketing start
2023-01-09
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin Dihydrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE500 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 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f1755cf3-bf7f-be40-e053-2a95a90a8536Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0220-1Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED13
80425-0220-1Azithromycin Dihydrate3 in 1 BLISTER PACKTABLET, FILM COATED33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0220-1EA - Each80425-022022a79a88-900b-42f3-b136-01e841c3680c12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0220AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]3Current NDC, Legacy NDC, 2 package rows20250102_f1755cf3-bf7f-be40-e053-2a95a90a8536.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
ndc (product): 80425-0220
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKf1755cf3-bf7f-be40-e053-2a95a90a85363
248656azithromycin 500 MG Oral TabletPSNf1755cf3-bf7f-be40-e053-2a95a90a85363
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNf1755cf3-bf7f-be40-e053-2a95a90a85363
248656azithromycin 500 MG Oral TabletSCDf1755cf3-bf7f-be40-e053-2a95a90a85363
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYf1755cf3-bf7f-be40-e053-2a95a90a85363
749780azithromycin 500 MG Oral Tablet 3 Count PackSYf1755cf3-bf7f-be40-e053-2a95a90a85363

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0220-1804250220011 BLISTER PACK in 1 CARTON (80425-0220-1) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-01-090000-00-00NoNoCurrent