FDA.reportPublic FDA data

Zithromax

Product NDC
0069-4061
11-digit product format
000694061
Labeler code
0069
Product ID
0069-4061_e15f2173-8700-4392-96a4-8560772b6f8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA050711
Marketing category
NDA
Marketing start
2019-05-17
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui105260, 141963, 211307, 212446, 226827, 248656, 308459, 308460, 749780, 749783, 750149, 750157

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0069-4061-012024-01-30C16284748780-11030e365-2717-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZITHROMAX ® safely and effectively. See full prescribing information for ZITHROMAX. ZITHROMAX (azithromycin) 250 mg and 500 mg tablets, for oral use ZITHROMAX (azithromycin) for oral suspension Initial U.S. Approval: 1991
0069-4061-752024-01-30C16284748780-11030e365-2717-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZITHROMAX ® safely and effectively. See full prescribing information for ZITHROMAX. ZITHROMAX (azithromycin) 250 mg and 500 mg tablets, for oral use ZITHROMAX (azithromycin) for oral suspension Initial U.S. Approval: 1991
0069-4061-892024-01-30C16284748780-11030e365-2717-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZITHROMAX ® safely and effectively. See full prescribing information for ZITHROMAX. ZITHROMAX (azithromycin) 250 mg and 500 mg tablets, for oral use ZITHROMAX (azithromycin) for oral suspension Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-4061-01Zithromax30 in 1 BOTTLETABLET, FILM COATED3048
0069-4061-75Zithromax3 in 1 BOXTABLET, FILM COATED348
0069-4061-75Zithromax6 in 1 BLISTER PACKTABLET, FILM COATED648
0069-4061-89Zithromax1 in 1 BLISTER PACKTABLET, FILM COATED148
0069-4061-89Zithromax50 in 1 BOX, UNIT-DOSETABLET, FILM COATED5048

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-4061-01EA - Each0069-4061053241b5-341a-4b69-b2c5-7bea7ca7ef1f12020-05-08
0069-4061-89EA - Each0069-4061724749d2-695d-4392-8081-e7818b11a03f12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-4061ZITHROMAX (AZITHROMYCIN DIHYDRATE) TABLET, FILM COATED ZITHROMAX (AZITHROMYCIN DIHYDRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]47Current NDC, Legacy NDC, 5 package rows20250205_db52b91e-79f7-4cc1-9564-f2eee8e31c45.zip

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
750149{6 (azithromycin 250 MG Oral Tablet [Zithromax]) } Pack [Z-PAK]BPCK1ebe30e0-271d-79a0-e063-6394a90abcf21
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK1ebe30e0-271d-79a0-e063-6394a90abcf21
308460azithromycin 250 MG Oral TabletPSN1ebe30e0-271d-79a0-e063-6394a90abcf21
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN1ebe30e0-271d-79a0-e063-6394a90abcf21
750149Z-PAK 6 Count PackPSN1ebe30e0-271d-79a0-e063-6394a90abcf21
212446Zithromax 250 MG Oral TabletPSN1ebe30e0-271d-79a0-e063-6394a90abcf21
212446azithromycin 250 MG Oral Tablet [Zithromax]SBD1ebe30e0-271d-79a0-e063-6394a90abcf21
308460azithromycin 250 MG Oral TabletSCD1ebe30e0-271d-79a0-e063-6394a90abcf21
749783azithromycin 250 MG Oral Tablet 6 Count PackSY1ebe30e0-271d-79a0-e063-6394a90abcf21
750149Z-PAKSY1ebe30e0-271d-79a0-e063-6394a90abcf21
212446Zithromax 250 MG Oral TabletSY1ebe30e0-271d-79a0-e063-6394a90abcf21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-4061-010006940610130 TABLET, FILM COATED in 1 BOTTLE (0069-4061-01) 2020-05-040000-00-00NoNoCurrent
0069-4061-75000694061753 in 1 BOXHistorical
0069-4061-890006940618950 BLISTER PACK in 1 BOX, UNIT-DOSE (0069-4061-89) > 1 TABLET, FILM COATED in 1 BLISTER PACK50 blister pack2019-07-180000-00-00NoNoCurrent