Azithromycin

Product NDC
63187-093
11-digit product format
631870093
Labeler code
63187
Product ID
63187-093_9d10dacc-ad17-48ec-b037-94987b2c40bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065246
Marketing category
ANDA
Marketing start
2010-12-17
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 · 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
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct63187-093EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63187-09363187-093-30EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63187-09363187-093-15EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
A065246-001AZITHROMYCINAZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05
A065246-002AZITHROMYCINAZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065246-001AB
A065246-002AB

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 UTC2026-02A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065246-001AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05782e0a99824c…
2021-12-28 21:50 UTC2021-12A065246-002AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-05782e0a99824c…

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 UTC2026-02A065246-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065246-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065246-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065246-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065246-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065246-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065246-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065246-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065246-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065246-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065246-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065246-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065246-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065246-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065246-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065246-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065246-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065246-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065246-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065246-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065246-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065246-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065246-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065246-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065246-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065246-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065246-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065246-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065246-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065246-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065246-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065246-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065246-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065246-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065246-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065246-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065246-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065246-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065246-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065246-002AB1782e0a99824c…

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
44134421-cb0b-4e85-a3c8-d58bdb476fadAvailable 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
63187-093-15Azithromycin15 mL in 1 BOTTLEPOWDER, FOR SUSPENSION156
63187-093-22Azithromycin22.5 mL in 1 BOTTLEPOWDER, FOR SUSPENSION22.56
63187-093-30Azithromycin30 mL in 1 BOTTLEPOWDER, FOR SUSPENSION306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-093-22ML - Milliliter63187-093a9ce2f12-b4c9-41fb-9845-cfb46d4853b312024-06-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]3
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]3
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIHAZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PAZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]3
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSINACTIVE INGREDIENTSX01TZO3QZAZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]3
SUCROSEINACTIVE INGREDIENTC151H8M554AZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-093AZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]6Current NDC, Legacy NDC, 3 package rows20240412_44134421-cb0b-4e85-a3c8-d58bdb476fad.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.ac327054-21ab-401c-a27a-48259db18f892026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065246
application number: ANDA065246
AzithromycinAZITHROMYCINA-S Medication Solutionsf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b2024-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065246
application number: ANDA065246
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.549cdd0a-da79-23b8-e054-00144ff8d46c2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065246
application number: ANDA065246
AzithromycinAZITHROMYCINProficient Rx LP44134421-cb0b-4e85-a3c8-d58bdb476fad2024-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065246
application number: ANDA065246
ndc (product): 63187-093
AzithromycinAZITHROMYCINSTATE HEALTH SERVICES, TEXAS DEPARTMENT OF2b821631-0df2-0fb2-e054-00144ff8d46c2024-02-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065246
application number: ANDA065246
AzithromycinAZITHROMYCINTeva Pharmaceuticals USA, Inc.3209b147-11ce-4eeb-8427-5f8e6fb2c83d2022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065246
application number: ANDA065246

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN44134421-cb0b-4e85-a3c8-d58bdb476fad6
141963azithromycin 40 MG/ML Oral SuspensionSCD44134421-cb0b-4e85-a3c8-d58bdb476fad6
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY44134421-cb0b-4e85-a3c8-d58bdb476fad6
141963azithromycin 200 MG per 5 ML Oral SuspensionSY44134421-cb0b-4e85-a3c8-d58bdb476fad6
141963azithromycin 600 MG per 15 ML Oral SuspensionSY44134421-cb0b-4e85-a3c8-d58bdb476fad6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-093-156318700931515 mL in 1 BOTTLE (63187-093-15) 15 ml2014-07-010000-00-00NoNoCurrent
63187-093-226318700932222.5 mL in 1 BOTTLE (63187-093-22) 22.5 ml2024-04-03NoNoCurrent
63187-093-306318700933030 mL in 1 BOTTLE (63187-093-30) 30 ml2014-07-010000-00-00NoNoCurrent