azithromycin

Product NDC
68071-2529
11-digit product format
680712529
Labeler code
68071
Product ID
68071-2529_cb6a5f8e-95f1-1d8b-e053-2a95a90a384e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
NDA050710
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1995-10-19
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
1200 mg/30mL
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct68071-2529IInactivated by FDA2026-08-11
excluded packagepackage68071-252968071-2529-3IInactivated by FDA2026-08-11

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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2529-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2529-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2529-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2529-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2529-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2529-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2529-3UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2529-3UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2529-3UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050710-001ZITHROMAXAZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-19
N050710-002ZITHROMAXAZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N050710-001AB
N050710-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050710-001ZITHROMAXEQ 100MG BASE/5MLFOR SUSPENSION / ORALABRLD1995-10-19782e0a99824c…
2021-12-28 21:50 UTC2021-12N050710-002ZITHROMAXEQ 200MG BASE/5MLFOR SUSPENSION / ORALABRLD, RS1995-10-19782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N050710-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050710-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050710-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050710-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050710-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050710-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050710-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050710-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050710-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050710-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050710-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050710-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050710-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050710-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050710-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050710-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050710-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050710-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050710-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050710-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050710-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050710-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050710-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050710-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050710-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050710-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050710-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050710-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050710-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050710-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050710-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050710-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050710-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050710-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050710-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050710-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050710-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050710-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050710-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N050710-002AB1782e0a99824c…

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2529-3azithromycin1 in 1 CARTONPOWDER, FOR SUSPENSION12
68071-2529-3azithromycin30 mL in 1 BOTTLEPOWDER, FOR SUSPENSION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2529AZITHROMYCIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20230715_cb6a684f-7f12-89df-e053-2a95a90acdee.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZithromaxAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer Incdb52b91e-79f7-4cc1-9564-f2eee8e31c452026-07-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 050710
application number: NDA050710

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141963azithromycin 200 MG in 5 mL Oral SuspensionPSNcb6a684f-7f12-89df-e053-2a95a90acdee2
141963azithromycin 40 MG/ML Oral SuspensionSCDcb6a684f-7f12-89df-e053-2a95a90acdee2
141963azithromycin 1200 MG per 30 ML Oral SuspensionSYcb6a684f-7f12-89df-e053-2a95a90acdee2
141963azithromycin 200 MG per 5 ML Oral SuspensionSYcb6a684f-7f12-89df-e053-2a95a90acdee2
141963azithromycin 600 MG per 15 ML Oral SuspensionSYcb6a684f-7f12-89df-e053-2a95a90acdee2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2529-3680712529031 BOTTLE in 1 CARTON (68071-2529-3) > 30 mL in 1 BOTTLE1 bottle2021-09-070000-00-00NoNoCurrent