Erythromycin

Product NDC
50090-4616
11-digit product format
500904616
Labeler code
50090
Product ID
50090-4616_cb89bd38-a0f0-4439-a91e-c08dda1e4509
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210954
Marketing category
ANDA
Marketing start
2019-07-07
Marketing end
0000-00-00
Substance
ERYTHROMYCIN
Active strength
333 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-4616IInactivated by FDA2026-08-17
excluded packagepackage50090-461650090-4616-0IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-4616-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4616-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4616-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4616-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4616-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4616-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4616-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4616-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4616-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4616-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4616-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4616-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4616-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4616-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4616-01332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210954-001ERYTHROMYCINERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2019-07-02
A210954-002ERYTHROMYCINERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2019-07-02
A210954-003ERYTHROMYCINERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2019-07-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A210954-001AB
A210954-002AB
A210954-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210954-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2019-07-02caaa826d4ba7…
2026-08-18 06:07:402026-07A210954-002ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2019-07-02caaa826d4ba7…
2026-08-18 06:07:402026-07A210954-003ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2019-07-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210954-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2019-07-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210954-002ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2019-07-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210954-003ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2019-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210954-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2019-07-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210954-002ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2019-07-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210954-003ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2019-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A210954-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2019-07-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210954-002ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2019-07-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210954-003ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2019-07-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210954-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2019-07-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210954-002ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2019-07-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210954-003ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2019-07-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210954-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2019-07-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210954-002ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2019-07-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210954-003ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2019-07-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210954-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2019-07-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210954-002ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2019-07-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210954-003ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2019-07-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210954-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2019-07-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210954-002ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2019-07-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210954-003ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2019-07-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210954-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2019-07-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210954-002ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2019-07-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210954-003ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2019-07-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210954-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2019-07-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210954-002ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2019-07-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210954-003ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2019-07-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210954-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2019-07-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A210954-002ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2019-07-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A210954-003ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2019-07-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210954-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2019-07-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210954-002ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2019-07-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210954-003ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2019-07-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210954-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2019-07-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210954-002ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2019-07-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210954-003ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2019-07-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210954-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2019-07-021e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210954-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210954-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210954-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210954-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210954-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210954-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210954-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210954-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210954-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210954-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210954-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210954-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210954-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210954-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210954-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210954-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210954-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210954-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210954-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210954-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210954-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210954-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210954-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210954-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210954-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210954-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210954-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210954-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210954-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210954-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210954-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210954-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210954-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210954-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210954-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210954-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210954-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210954-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210954-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210954-001AB11e350fbaab3a…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4616-02023-01-30C16284748780-1f386c64a-40ba-0266-e053-dadaa90a7c1aErythromycin Delayed-Release Tablets, USP (250 mg, 333 mg and 500 mg) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4616-0Erythromycin30 in 1 BOTTLETABLET, DELAYED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4616ERYTHROMYCIN TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20191102_29a56565-4a92-4626-9567-5592d661a896.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
ErythromycinERYTHROMYCINAmneal Pharmaceuticals NY LLCbb641ed4-8093-4e15-9cb9-8921b1093d502024-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210954
application number: ANDA210954

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315090erythromycin 333 MG Delayed Release Oral TabletPSN29a56565-4a92-4626-9567-5592d661a8962
315090erythromycin 333 MG Delayed Release Oral TabletSCD29a56565-4a92-4626-9567-5592d661a8962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4616-05009046160030 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-4616-0) 2019-10-160000-00-00NoNoCurrent