Azithromycin Dihydrate

Product NDC
80425-0218
11-digit product format
804250218
Labeler code
80425
Product ID
80425-0218_2a9aa671-d0a1-2254-e063-6294a90a9f79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA208250
Marketing category
ANDA
Marketing start
2023-01-09
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 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
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
Listing expiration
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308460Internal 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
f1752913-85ac-01fa-e053-2995a90a2bd8Available 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
80425-0218-1Azithromycin Dihydrate6 in 1 BLISTER PACKTABLET, FILM COATED63
80425-0218-1Azithromycin Dihydrate1 in 1 BOXTABLET, FILM COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0218-1EA - Each80425-0218333f4413-a072-4689-8ece-7cac968bbfb312023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0218AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, Legacy NDC, 2 package rows20250102_f1752913-85ac-01fa-e053-2995a90a2bd8.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
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
ndc (product): 80425-0218
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
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf1752913-85ac-01fa-e053-2995a90a2bd83
308460azithromycin 250 MG Oral TabletPSNf1752913-85ac-01fa-e053-2995a90a2bd83
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf1752913-85ac-01fa-e053-2995a90a2bd83
308460azithromycin 250 MG Oral TabletSCDf1752913-85ac-01fa-e053-2995a90a2bd83
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf1752913-85ac-01fa-e053-2995a90a2bd83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0218-1804250218011 BLISTER PACK in 1 BOX (80425-0218-1) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-01-090000-00-00NoNoCurrent