azithromycin

Product NDC
59762-3051
11-digit product format
597623051
Labeler code
59762
Product ID
59762-3051_b524bc31-a46c-41f5-a2d5-40166d1ec6c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Greenstone LLC
Application
NDA050693
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1999-02-12
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
1 g/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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59762-3051DDiscontinued by firm2026-08-17
excluded packagepackage59762-305159762-3051-1DDiscontinued by firm2026-08-17
excluded packagepackage59762-305159762-3051-2DDiscontinued by firm2026-08-17

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 packagepackage59762-305159762-3051-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N050693-001ZITHROMAXAZITHROMYCINEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD1994-09-28

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD1994-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD1994-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD1994-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD1994-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-283f01610625f2…
2019-09-15 20:21 UTC2019-09N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050693-001ZITHROMAXEQ 1GM BASE/PACKETFOR SUSPENSION / ORALRLD, RS1994-09-28e64feba35796…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-3051-1EA - Each59762-305132906e18-60c6-4dbb-ab1e-b44cb6e29a1312012-07-24
59762-3051-2EA - Each59762-3051399898d4-5993-442f-95e5-937401b3dedc12012-07-24
59762-3051-5EA - Each59762-30511cf6569f-c8e7-4e9b-a53f-0097c4585ae312021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN DIHYDRATEACTIVE INGREDIENT5FD1131I7SAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSINACTIVE INGREDIENTSX01TZO3QZAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
SUCROSEINACTIVE INGREDIENTC151H8M554AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
TRIACETININACTIVE INGREDIENTXHX3C3X673AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]18
AZITHROMYCIN DIHYDRATEACTIVE INGREDIENT5FD1131I7SAZITHROMYCIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]7
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]7
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSINACTIVE INGREDIENTSX01TZO3QZAZITHROMYCIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]7
SUCROSEINACTIVE INGREDIENTC151H8M554AZITHROMYCIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]7
azithromycinACTIVE INGREDIENTF94OW58Y8VAZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2
AZITHROMYCIN DIHYDRATEACTIVE INGREDIENT5FD1131I7SAZITHROMYCIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
azithromycinACTIVE MOIETYF94OW58Y8VAZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2
sodium phosphate, tribasic anhydrousINACTIVE INGREDIENTSX01TZO3QZAZITHROMYCIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
sodium phosphate, tribasic anhydrousINACTIVE INGREDIENTSX01TZO3QZAZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2
sucroseINACTIVE INGREDIENTC151H8M554AZITHROMYCIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
sucroseINACTIVE INGREDIENTC151H8M554AZITHROMYCIN POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-3051AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN POWDER, FOR SUSPENSION [GREENSTONE LLC]36Legacy NDC20250206_d470695c-c0d7-4361-8783-45f58a932ac4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861416azithromycin 1 GM Powder for Oral SuspensionPSN0188acfd-cc89-4486-8bcf-93a53340dfca5
861416azithromycin 1000 MG Powder for Oral SuspensionSCD0188acfd-cc89-4486-8bcf-93a53340dfca5
861416azithromycin 1 GM Powder for Oral SuspensionSY0188acfd-cc89-4486-8bcf-93a53340dfca5
861416azithromycin 1000 MG Powder for Oral SuspensionSY0188acfd-cc89-4486-8bcf-93a53340dfca5
861416azithromycin 1 GM Powder for Oral SuspensionPSN53e2801a-323d-448e-8278-92d672904b0f2
861416azithromycin 1 GM Powder for Oral SuspensionPSN5a96f4e1-6b80-42a2-8d85-95a1ff8920992
861416azithromycin 1000 MG Powder for Oral SuspensionSCD53e2801a-323d-448e-8278-92d672904b0f2
861416azithromycin 1000 MG Powder for Oral SuspensionSCD5a96f4e1-6b80-42a2-8d85-95a1ff8920992
861416azithromycin 1 GM Powder for Oral SuspensionSY53e2801a-323d-448e-8278-92d672904b0f2
861416azithromycin 1 GM Powder for Oral SuspensionSY5a96f4e1-6b80-42a2-8d85-95a1ff8920992
861416azithromycin 1000 MG Powder for Oral SuspensionSY53e2801a-323d-448e-8278-92d672904b0f2
861416azithromycin 1000 MG Powder for Oral SuspensionSY5a96f4e1-6b80-42a2-8d85-95a1ff8920992

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-3051-15976230510110 PACKET in 1 BOX (59762-3051-1) > 1 POWDER, FOR SUSPENSION in 1 PACKET (59762-3051-5) 10 packet1999-02-120000-00-00NoNoCurrent
59762-3051-2597623051023 PACKET in 1 BOX (59762-3051-2) > 1 POWDER, FOR SUSPENSION in 1 PACKET (59762-3051-5) 3 packet1999-02-120000-00-00NoNoCurrent