FDA.reportPublic FDA data

Erythromycin

Product NDC
46708-398
11-digit product format
467080398
Labeler code
46708
Product ID
46708-398_904b9ab6-9a2a-47f3-8a38-04920ce696e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA215661
Marketing category
ANDA
Marketing start
2023-08-28
Substance
ERYTHROMYCIN
Active strength
500 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [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
A215661-001ERYTHROMYCINERYTHROMYCIN250MGTABLET / ORALAB2023-08-24
A215661-002ERYTHROMYCINERYTHROMYCIN500MGTABLET / ORALAB2023-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215661-001AB
A215661-002AB

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 22:54:322026-06A215661-001ERYTHROMYCIN250MGTABLET / ORALAB2023-08-24a50c72e98297…
2026-08-01 22:54:322026-06A215661-002ERYTHROMYCIN500MGTABLET / ORALAB2023-08-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A215661-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A215661-002AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ErythromycinERYTHROMYCINAlembic Pharmaceuticals Limited904b9ab6-9a2a-47f3-8a38-04920ce696e02023-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215661
application number: ANDA215661
ndc (product): 46708-398
ErythromycinERYTHROMYCINAlembic Pharmaceuticals Inc.383f9011-a3e0-4d7d-b058-5f8ab319dc8c2023-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215661
application number: ANDA215661

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERYTHROMYCIN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
63937KV33DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197650Internal RxNorm lookup
598006Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
904b9ab6-9a2a-47f3-8a38-04920ce696e0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d329c2e1-5ae8-4e64-aea0-77ecea3fa1abProduct name320250717
3b331500-3b74-bd2b-fede-d46839f2f4d5Product name620240313
fdae2630-eae0-4769-abfd-8f33d5b771b4Product name320240202
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
64ae94c0-3212-d73a-92da-9e6dd85c6ebeProduct name220180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9Product name220170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
57850177-5927-151f-e1fa-7e2ca47f81e5Product name120140508
8ee71591-1d8f-e24e-242b-bfef131e3168Product name120140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-398-30Erythromycin30 in 1 BOTTLETABLET, FILM COATED301
46708-398-31Erythromycin100 in 1 BOTTLETABLET, FILM COATED1001
46708-398-91Erythromycin1000 in 1 BOTTLETABLET, FILM COATED10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-398ERYTHROMYCIN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 3 package rows20230830_904b9ab6-9a2a-47f3-8a38-04920ce696e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
598006erythromycin 250 MG Oral TabletPSN904b9ab6-9a2a-47f3-8a38-04920ce696e01
197650erythromycin 500 MG Oral TabletPSN904b9ab6-9a2a-47f3-8a38-04920ce696e01
598006erythromycin 250 MG Oral TabletSCD904b9ab6-9a2a-47f3-8a38-04920ce696e01
197650erythromycin 500 MG Oral TabletSCD904b9ab6-9a2a-47f3-8a38-04920ce696e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-398-304670803983030 TABLET, FILM COATED in 1 BOTTLE (46708-398-30) 2023-08-28NoNoCurrent
46708-398-3146708039831100 TABLET, FILM COATED in 1 BOTTLE (46708-398-31) 2023-08-28NoNoCurrent
46708-398-91467080398911000 TABLET, FILM COATED in 1 BOTTLE (46708-398-91) 2023-08-28NoNoCurrent