FDA.reportPublic FDA data

azithromycin dihydrate

Product NDC
70436-228
11-digit product format
704360228
Labeler code
70436
Product ID
70436-228_32f66ed6-7a90-559b-e063-6394a90aaf93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin dihydrate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA217036
Marketing category
ANDA
Marketing start
2024-01-01
Substance
AZITHROMYCIN DIHYDRATE
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

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
A217036-001AZITHROMYCINAZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2023-07-27
A217036-002AZITHROMYCINAZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2023-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217036-001AB
A217036-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A217036-001AZITHROMYCINEQ 100MG BASE/5MLFOR SUSPENSION / ORALAB2023-07-27a50c72e98297…
2026-08-01 22:54:322026-06A217036-002AZITHROMYCINEQ 200MG BASE/5MLFOR SUSPENSION / ORALAB2023-07-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217036-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A217036-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINAiPing Pharmaceutical, Inc.d6fb42ed-7dac-4a7b-9964-d367dd47dd5c2026-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217036
application number: ANDA217036
AzithromycinAZITHROMYCINZhejiang Poly Pharm. Co., Ltd.33d0a4eb-5076-65c6-e063-6394a90ac13a2025-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217036
application number: ANDA217036
azithromycin dihydrateAZITHROMYCIN DIHYDRATESlate Run Pharmaceuticals, LLC33d4ac05-b564-440c-971d-b78590dd2c322025-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217036
application number: ANDA217036
ndc (product): 70436-228

Additional Listing Data#

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

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 · 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
33d4ac05-b564-440c-971d-b78590dd2c32Available 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
70436-228-49azithromycin dihydrate22.5 mL in 1 BOTTLEPOWDER, FOR SUSPENSION22.56
70436-228-49azithromycin dihydrate1 in 1 CARTONPOWDER, FOR SUSPENSION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-228-49ML - Milliliter70436-228bffda811-872a-44d2-8a17-20bd712af95612024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-228AZITHROMYCIN DIHYDRATE POWDER, FOR SUSPENSION [SLATE RUN PHARMACEUTICALS, LLC]6Current NDC, 2 package rows20250418_33d4ac05-b564-440c-971d-b78590dd2c32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN33d4ac05-b564-440c-971d-b78590dd2c326
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN33d4ac05-b564-440c-971d-b78590dd2c326
308459azithromycin 20 MG/ML Oral SuspensionSCD33d4ac05-b564-440c-971d-b78590dd2c326
141963azithromycin 40 MG/ML Oral SuspensionSCD33d4ac05-b564-440c-971d-b78590dd2c326
308459azithromycin 100 MG per 5 ML Oral SuspensionSY33d4ac05-b564-440c-971d-b78590dd2c326
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY33d4ac05-b564-440c-971d-b78590dd2c326
141963azithromycin 200 MG per 5 ML Oral SuspensionSY33d4ac05-b564-440c-971d-b78590dd2c326
141963azithromycin 600 MG per 15 ML Oral SuspensionSY33d4ac05-b564-440c-971d-b78590dd2c326

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70436-228-49704360228491 BOTTLE in 1 CARTON (70436-228-49) / 22.5 mL in 1 BOTTLE1 bottle2024-06-07NoNoCurrent