Azithromycin

Product NDC
68071-4976
Requested package NDC
68071-4976-3
11-digit product format
680714976
Labeler code
68071
Product ID
68071-4976_1b2e96de-5ed6-c9e9-e063-6394a90a472e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207398
Marketing category
ANDA
Marketing start
2018-07-05
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

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 · 3 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
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-497668071-4976-3IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-497668071-4976-3IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-497668071-4976-3IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
A207398-001AZITHROMYCINAZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207398-001AB

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 UTC2026-02A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-053f01610625f2…
2019-09-15 20:21 UTC2019-09A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207398-001AZITHROMYCINEQ 500MG BASETABLET / ORALAB2018-07-05cb3db0bc1861…

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 UTC2026-02A207398-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207398-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207398-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207398-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207398-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207398-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207398-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207398-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207398-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207398-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207398-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207398-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207398-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207398-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207398-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207398-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207398-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207398-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207398-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207398-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207398-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207398-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207398-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207398-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207398-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207398-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207398-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207398-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207398-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207398-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207398-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207398-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207398-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207398-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207398-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207398-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207398-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207398-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207398-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207398-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin
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
8e7184e1-3c3c-cd87-e053-2a95a90a6eb6Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4976-3Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4976AZITHROMYCIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240619_8e7184e1-3c3c-cd87-e053-2a95a90a6eb6.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINA-S Medication Solutions882f71b1-b153-4856-b4a7-1a29ae9cf2472026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207398
application number: ANDA207398
AzithromycinAZITHROMYCINA-S Medication Solutions58308e8b-57bd-4e82-a2e8-24aac63194cd2026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207398
application number: ANDA207398
AzithromycinAZITHROMYCINBryant Ranch Prepack2a8010dc-700f-45d3-94ca-ebe4a51acc1b2026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207398
application number: ANDA207398
AzithromycinAZITHROMYCINAurobindo Pharma Limited795c13cd-e9ca-481b-9fa9-2890bdf9dac82026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207398
application number: ANDA207398
AzithromycinAZITHROMYCINBryant Ranch Prepacka81212ef-76b6-4bd7-8706-3d2b05ee34f92026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207398
application number: ANDA207398
AzithromycinAZITHROMYCINA-S Medication Solutions24c07398-84ad-48e2-9625-e9073c28fb732026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207398
application number: ANDA207398
AzithromycinAZITHROMYCINA-S Medication Solutions77c5e4c6-6d16-40fe-bf36-cb441348f39b2026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207398
application number: ANDA207398
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.003307c5-3f73-4a5d-a704-bfdea3c656e82026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207398
application number: ANDA207398
AzithromycinAZITHROMYCINRedpharm Drug2fd25741-f014-3999-e063-6394a90acdd02025-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207398
application number: ANDA207398
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.94e17ae5-0871-67a0-e053-2995a90ae0ae2025-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207398
application number: ANDA207398
AZITHROMYCINAZITHROMYCINDirect_Rx8e6e11fb-eb9e-28ec-e053-2a95a90aa1a32025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207398
application number: ANDA207398
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.9270e676-3382-6483-e053-2a95a90a556e2024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207398
application number: ANDA207398
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.8e7184e1-3c3c-cd87-e053-2a95a90a6eb62024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207398
application number: ANDA207398
ndc (package): 68071-4976-3
ndc (product): 68071-4976
ndc11 (package): 68071497603
AzithromycinAZITHROMYCINProficient Rx LP25f2d819-ae38-4061-a897-bbcfce3739bf2022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207398
application number: ANDA207398

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK8e7184e1-3c3c-cd87-e053-2a95a90a6eb63
248656azithromycin 500 MG Oral TabletPSN8e7184e1-3c3c-cd87-e053-2a95a90a6eb63
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN8e7184e1-3c3c-cd87-e053-2a95a90a6eb63
248656azithromycin 500 MG Oral TabletSCD8e7184e1-3c3c-cd87-e053-2a95a90a6eb63
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY8e7184e1-3c3c-cd87-e053-2a95a90a6eb63
749780azithromycin 500 MG Oral Tablet 3 Count PackSY8e7184e1-3c3c-cd87-e053-2a95a90a6eb63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4976-3680714976033 TABLET, FILM COATED in 1 BLISTER PACK (68071-4976-3) 2019-07-240000-00-00NoNoCurrent