AZITHROMYCIN

Product NDC
68071-4773
11-digit product format
680714773
Labeler code
68071
Product ID
68071-4773_1adbfa42-59d2-ee83-e063-6394a90ab827
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207531
Marketing category
ANDA
Marketing start
2018-04-10
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
200 mg/5mL
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 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-4773-5557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-4773-58af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-4773-5834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-4773-51332a3947898…d4bfe170f9cd…

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
A207531-001AZITHROMYCINAZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09
A207531-002AZITHROMYCINAZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207531-001AB
A207531-002AB

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 UTC2026-02A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207531-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09782e0a99824c…
2021-12-28 21:50 UTC2021-12A207531-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2018-04-09782e0a99824c…

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 UTC2026-02A207531-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207531-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207531-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207531-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207531-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207531-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207531-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207531-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207531-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207531-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207531-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207531-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207531-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207531-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207531-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207531-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207531-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207531-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207531-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207531-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207531-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207531-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207531-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207531-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207531-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207531-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207531-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207531-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207531-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207531-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207531-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207531-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207531-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207531-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207531-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207531-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207531-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207531-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207531-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207531-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN MONOHYDRATE200 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JTE4MNN1MDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
141963Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
82454fb2-e524-ecb8-e053-2991aa0a6e7cAvailable 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
68071-4773-5AZITHROMYCIN15 mL in 1 BOTTLEPOWDER, FOR SUSPENSION155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4773AZITHROMYCIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20240816_82454fb2-e524-ecb8-e053-2991aa0a6e7c.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZITHROMYCINAZITHROMYCINA-S Medication Solutions76093152-e2d7-4fe1-8568-1f0fec1747c22026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals, Inc.9e4fbd52-43e4-4d87-a136-f4d680a8d0c12026-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
AZITHROMYCINAZITHROMYCINA-S Medication Solutions405ab07f-7d1d-4552-ad3b-2a03be8e99492026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
AZITHROMYCINAZITHROMYCINEpic Pharma, LLC59c4b783-4ff7-4269-969b-58a10e12b12b2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
AZITHROMYCINAZITHROMYCINPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS714f6f55-278a-4fcf-8d4e-2ad9b43623a32025-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals, Inc.3f7c7421-411d-c04e-e063-6394a90a4aa02025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
AZITHROMYCINAZITHROMYCINDirectRxd564d91e-3039-c120-e053-2995a90ae6db2025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.90a506cd-aae7-a622-e053-2a95a90ad3522024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.82454fb2-e524-ecb8-e053-2991aa0a6e7c2024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
ndc (product): 68071-4773
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.8389c336-25eb-a96f-e053-2a91aa0a0dd82024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
AZITHROMYCINAZITHROMYCINProficient Rx LPe1172805-0930-4fb9-8a2f-e0d6a04306302022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531
AZITHROMYCINAZITHROMYCINProficient Rx LPb3761d39-9b79-4908-8b05-a1c91e5999982022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207531
application number: ANDA207531

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN82454fb2-e524-ecb8-e053-2991aa0a6e7c5
141963azithromycin 40 MG/ML Oral SuspensionSCD82454fb2-e524-ecb8-e053-2991aa0a6e7c5
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY82454fb2-e524-ecb8-e053-2991aa0a6e7c5
141963azithromycin 200 MG per 5 ML Oral SuspensionSY82454fb2-e524-ecb8-e053-2991aa0a6e7c5
141963azithromycin 600 MG per 15 ML Oral SuspensionSY82454fb2-e524-ecb8-e053-2991aa0a6e7c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4773-46807147730415 mL in 1 BOTTLE (68071-4773-4) 15 ml2019-02-190000-00-00NoNoCurrent
68071-4773-56807147730515 mL in 1 BOTTLE (68071-4773-5) 15 ml2019-02-190000-00-00NoNoCurrent