Zithromax

Product NDC
0069-3120
11-digit product format
000693120
Labeler code
0069
Product ID
0069-3120_e15f2173-8700-4392-96a4-8560772b6f8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin dihydrate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA050710
Marketing category
NDA
Marketing start
1995-10-19
Substance
AZITHROMYCIN DIHYDRATE
Active strength
200 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
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Zithromax
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE200 mg/5mL

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 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
105260Internal RxNorm lookup
141963Internal RxNorm lookup
211307Internal RxNorm lookup
212446Internal RxNorm lookup
226827Internal RxNorm lookup
248656Internal RxNorm lookup
308459Internal RxNorm lookup
308460Internal RxNorm lookup
749780Internal RxNorm lookup
749783Internal RxNorm lookup
750149Internal RxNorm lookup
750157Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
db52b91e-79f7-4cc1-9564-f2eee8e31c45Available 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
0069-3120-19Zithromax15 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1548
0069-3120-19Zithromax1 in 1 CARTONPOWDER, FOR SUSPENSION148

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-3120-19ML - Milliliter0069-3120e620f125-61c9-44cd-9f06-cd014c69f8b112012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-3120ZITHROMAX (AZITHROMYCIN DIHYDRATE) TABLET, FILM COATED ZITHROMAX (AZITHROMYCIN DIHYDRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]47Current NDC, Legacy NDC, 2 package rows20250205_db52b91e-79f7-4cc1-9564-f2eee8e31c45.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
ndc (product): 0069-3120

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
750157{3 (azithromycin 500 MG Oral Tablet [Zithromax]) } Pack [TRI-PAK]BPCKdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
750149{6 (azithromycin 250 MG Oral Tablet [Zithromax]) } Pack [Z-PAK]BPCKdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
308459azithromycin 100 MG in 5 mL Oral SuspensionPSNdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
141963azithromycin 200 MG in 5 mL Oral SuspensionPSNdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
308460azithromycin 250 MG Oral TabletPSNdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
248656azithromycin 500 MG Oral TabletPSNdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
750149Z-PAK 6 Count PackPSNdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
211307Zithromax 100 MG in 5 mL Oral SuspensionPSNdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
105260Zithromax 200 MG in 5 mL Oral SuspensionPSNdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
212446Zithromax 250 MG Oral TabletPSNdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
226827Zithromax 500 MG Oral TabletPSNdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
750157Zithromax TRI-PAK, 3 CountPSNdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
211307azithromycin 20 MG/ML Oral Suspension [Zithromax]SBDdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
212446azithromycin 250 MG Oral Tablet [Zithromax]SBDdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
105260azithromycin 40 MG/ML Oral Suspension [Zithromax]SBDdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
226827azithromycin 500 MG Oral Tablet [Zithromax]SBDdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
308459azithromycin 20 MG/ML Oral SuspensionSCDdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
308460azithromycin 250 MG Oral TabletSCDdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
141963azithromycin 40 MG/ML Oral SuspensionSCDdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
248656azithromycin 500 MG Oral TabletSCDdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
308459azithromycin 100 MG per 5 ML Oral SuspensionSYdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
141963azithromycin 1200 MG per 30 ML Oral SuspensionSYdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
141963azithromycin 200 MG per 5 ML Oral SuspensionSYdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
749783azithromycin 250 MG Oral Tablet 6 Count PackSYdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
749780azithromycin 500 MG Oral Tablet 3 Count PackSYdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
141963azithromycin 600 MG per 15 ML Oral SuspensionSYdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
750157TRI-PAKSYdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
750149Z-PAKSYdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
211307Zithromax 100 MG per 5 ML Oral SuspensionSYdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
211307Zithromax 20 MG/ML Oral SuspensionSYdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
105260Zithromax 200 MG per 5 ML Oral SuspensionSYdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
212446Zithromax 250 MG Oral TabletSYdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
105260Zithromax 40 MG/ML Oral SuspensionSYdb52b91e-79f7-4cc1-9564-f2eee8e31c4548
226827Zithromax 500 MG Oral TabletSYdb52b91e-79f7-4cc1-9564-f2eee8e31c4548

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-3120-19000693120191 BOTTLE in 1 CARTON (0069-3120-19) / 15 mL in 1 BOTTLE1 bottle1995-10-190000-00-00NoNoCurrent