AZITHROMYCIN

Product NDC
42806-147
11-digit product format
428060147
Labeler code
42806
Product ID
42806-147_8d7e7ebd-9d6a-43a9-9a4b-035cd258ff65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA207531
Marketing category
ANDA
Marketing start
2018-04-10
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
100 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN MONOHYDRATE100 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
141963Internal RxNorm lookup
308459Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
59c4b783-4ff7-4269-969b-58a10e12b12bAvailable 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
42806-147-31AZITHROMYCIN15 mL in 1 BOTTLE, PLASTICPOWDER, FOR SUSPENSION1516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-147-31ML - Milliliter42806-147f6564f97-17d9-4529-8a3d-93f8a047e30112018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-147AZITHROMYCIN POWDER, FOR SUSPENSION [EPIC PHARMA, LLC]14Current NDC, Legacy NDC, 1 package rows20221230_59c4b783-4ff7-4269-969b-58a10e12b12b.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
ndc (product): 42806-147
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
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
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN59c4b783-4ff7-4269-969b-58a10e12b12b16
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN59c4b783-4ff7-4269-969b-58a10e12b12b16
308459azithromycin 20 MG/ML Oral SuspensionSCD59c4b783-4ff7-4269-969b-58a10e12b12b16
141963azithromycin 40 MG/ML Oral SuspensionSCD59c4b783-4ff7-4269-969b-58a10e12b12b16
308459azithromycin 100 MG per 5 ML Oral SuspensionSY59c4b783-4ff7-4269-969b-58a10e12b12b16
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY59c4b783-4ff7-4269-969b-58a10e12b12b16
141963azithromycin 200 MG per 5 ML Oral SuspensionSY59c4b783-4ff7-4269-969b-58a10e12b12b16
141963azithromycin 600 MG per 15 ML Oral SuspensionSY59c4b783-4ff7-4269-969b-58a10e12b12b16
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN90a506cd-aae7-a622-e053-2a95a90ad3523
308459azithromycin 20 MG/ML Oral SuspensionSCD90a506cd-aae7-a622-e053-2a95a90ad3523
308459azithromycin 100 MG per 5 ML Oral SuspensionSY90a506cd-aae7-a622-e053-2a95a90ad3523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-147-314280601473115 mL in 1 BOTTLE, PLASTIC (42806-147-31) 15 ml2018-04-100000-00-00NoNoCurrent