Erythromycin

Product NDC
72241-037
11-digit product format
722410037
Labeler code
72241
Product ID
72241-037_eb7928f4-e0c7-4f23-a1a8-934d82f5eca4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA213628
Marketing category
ANDA
Marketing start
2021-07-31
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
A213628-001ERYTHROMYCINERYTHROMYCIN250MGTABLET / ORALAB2021-06-28
A213628-002ERYTHROMYCINERYTHROMYCIN500MGTABLET / ORALABRS2021-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213628-001AB
A213628-002AB

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 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213628-002ERYTHROMYCIN500MGTABLET / ORALABRS2021-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213628-002ERYTHROMYCIN500MGTABLET / ORALABRS2021-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213628-002ERYTHROMYCIN500MGTABLET / ORALABRS2021-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213628-002ERYTHROMYCIN500MGTABLET / ORALABRS2021-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213628-002ERYTHROMYCIN500MGTABLET / ORALABRS2021-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213628-002ERYTHROMYCIN500MGTABLET / ORALABRS2021-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213628-002ERYTHROMYCIN500MGTABLET / ORALABRS2021-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213628-002ERYTHROMYCIN500MGTABLET / ORALABRS2021-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213628-002ERYTHROMYCIN500MGTABLET / ORALABRS2021-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A213628-002ERYTHROMYCIN500MGTABLET / ORALABRS2021-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213628-002ERYTHROMYCIN500MGTABLET / ORALABRS2021-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213628-002ERYTHROMYCIN500MGTABLET / ORALABRS2021-06-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213628-002ERYTHROMYCIN500MGTABLET / ORALABRS2021-06-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213628-002ERYTHROMYCIN500MGTABLET / ORALABRS2021-06-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213628-002ERYTHROMYCIN500MGTABLET / ORALAB2021-06-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213628-002ERYTHROMYCIN500MGTABLET / ORALAB2021-06-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213628-002ERYTHROMYCIN500MGTABLET / ORALAB2021-06-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213628-002ERYTHROMYCIN500MGTABLET / ORALAB2021-06-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A213628-002ERYTHROMYCIN500MGTABLET / ORALAB2021-06-28782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213628-001ERYTHROMYCIN250MGTABLET / ORALAB2021-06-286a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213628-002ERYTHROMYCIN500MGTABLET / ORALABRS2021-06-286a51e52b5d6a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213628-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213628-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213628-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213628-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213628-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213628-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213628-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213628-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213628-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213628-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213628-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213628-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213628-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213628-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213628-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213628-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213628-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213628-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213628-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213628-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213628-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213628-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213628-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213628-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213628-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213628-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213628-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213628-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213628-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213628-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213628-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213628-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213628-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213628-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213628-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213628-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213628-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A213628-002AB1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213628-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213628-002AB16a51e52b5d6a…

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
bc3d091b-1fc8-4f7a-a3c2-8ede87f5faa0Available 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
72241-037-05Erythromycin100 in 1 BOTTLETABLET, FILM COATED1002
72241-037-22Erythromycin30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-037ERYTHROMYCIN TABLET, FILM COATED [MODAVAR PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20231224_bc3d091b-1fc8-4f7a-a3c2-8ede87f5faa0.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ERYTHROMYCINERYTHROMYCINNivagen Pharmaceuticals, Inc.aa61cb37-5fc5-4225-b894-1d660386777f2024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213628
application number: ANDA213628
ErythromycinERYTHROMYCINModavar Pharmaceuticals LLCbc3d091b-1fc8-4f7a-a3c2-8ede87f5faa02023-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213628
application number: ANDA213628
ndc (product): 72241-037
ErythromycinERYTHROMYCINCadila Pharmaceuticals Limitedfae8fc38-3c60-43b8-a0f9-2c50df3325052023-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213628
application number: ANDA213628
ErythromycinERYTHROMYCINOrange Pharmaceuticals USA LLC379ed8f7-b54f-495f-932e-cd0e4c6911342021-07-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213628
application number: ANDA213628

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
598006erythromycin 250 MG Oral TabletPSNbc3d091b-1fc8-4f7a-a3c2-8ede87f5faa02
197650erythromycin 500 MG Oral TabletPSNbc3d091b-1fc8-4f7a-a3c2-8ede87f5faa02
598006erythromycin 250 MG Oral TabletSCDbc3d091b-1fc8-4f7a-a3c2-8ede87f5faa02
197650erythromycin 500 MG Oral TabletSCDbc3d091b-1fc8-4f7a-a3c2-8ede87f5faa02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72241-037-0572241003705100 TABLET, FILM COATED in 1 BOTTLE (72241-037-05) 2021-07-310000-00-00NoNoCurrent
72241-037-227224100372230 TABLET, FILM COATED in 1 BOTTLE (72241-037-22) 2021-07-310000-00-00NoNoCurrent