Erythromycin

Product NDC
55289-025
Requested package NDC
55289-025-04
11-digit product format
552890025
Labeler code
55289
Product ID
55289-025_e6e99fde-0aed-67d8-e053-2a95a90a32b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA061621
Marketing category
ANDA
Marketing start
2011-09-06
Marketing end
0000-00-00
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55289-02555289-025-04DDiscontinued by firm2026-08-03

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55289-02555289-025-04DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A061621-001ERYTHROMYCINERYTHROMYCIN250MGTABLET / ORALABApproved before 1982
A061621-002ERYTHROMYCINERYTHROMYCIN500MGTABLET / ORALABApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A061621-001AB
A061621-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061621-002ERYTHROMYCIN500MGTABLET / ORALABApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061621-002ERYTHROMYCIN500MGTABLET / ORALABApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061621-002ERYTHROMYCIN500MGTABLET / ORALABApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061621-002ERYTHROMYCIN500MGTABLET / ORALABApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061621-002ERYTHROMYCIN500MGTABLET / ORALABApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061621-002ERYTHROMYCIN500MGTABLET / ORALABApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061621-002ERYTHROMYCIN500MGTABLET / ORALABApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061621-002ERYTHROMYCIN500MGTABLET / ORALABApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061621-002ERYTHROMYCIN500MGTABLET / ORALABApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A061621-002ERYTHROMYCIN500MGTABLET / ORALABApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061621-002ERYTHROMYCIN500MGTABLET / ORALABApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061621-002ERYTHROMYCIN500MGTABLET / ORALABApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061621-002ERYTHROMYCIN500MGTABLET / ORALABApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A061621-002ERYTHROMYCIN500MGTABLET / ORALABApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061621-002ERYTHROMYCIN500MGTABLET / ORALABRS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A061621-002ERYTHROMYCIN500MGTABLET / ORALABRS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A061621-002ERYTHROMYCIN500MGTABLET / ORALABRS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A061621-002ERYTHROMYCIN500MGTABLET / ORALABRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A061621-002ERYTHROMYCIN500MGTABLET / ORALABRS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A061621-001ERYTHROMYCIN250MGTABLET / ORALABApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12A061621-002ERYTHROMYCIN500MGTABLET / ORALABRS, Approved before 1982782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A061621-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061621-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061621-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061621-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A061621-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061621-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061621-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061621-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061621-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061621-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061621-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061621-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061621-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061621-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061621-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061621-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061621-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061621-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A061621-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A061621-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061621-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061621-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061621-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061621-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061621-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061621-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A061621-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A061621-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061621-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061621-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A061621-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A061621-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A061621-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A061621-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A061621-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A061621-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A061621-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A061621-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A061621-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A061621-002AB1782e0a99824c…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-025-04EA - Each55289-0250ec07be5-2cfa-4a15-9805-574e32e2afdc12013-02-13
55289-025-20EA - Each55289-02500f92413-7b54-4e10-88ac-dd88ddfb460f12013-02-13
55289-025-28EA - Each55289-0253c179513-0364-4ad4-8623-8bc513acb14512013-02-13
55289-025-30EA - Each55289-025916f7372-d44f-48ea-8678-7723b25b03b712013-02-13
55289-025-40EA - Each55289-0256be6ab10-85ac-4e1e-9ea6-de6650d0cacf12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ErythromycinACTIVE INGREDIENT63937KV33DERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
ErythromycinACTIVE MOIETY63937KV33DERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933ERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
crospovidoneINACTIVE INGREDIENT68401960MKERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
D&C Red No. 30INACTIVE INGREDIENT2S42T2808BERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30ERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
povidoneINACTIVE INGREDIENTFZ989GH94EERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4ERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
sorbic acidINACTIVE INGREDIENTX045WJ989BERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
sorbitan monooleateINACTIVE INGREDIENT06XEA2VD56ERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPERYTHROMYCIN BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-025ERYTHROMYCIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]19Legacy NDC20241011_5d19702d-bb87-4f6b-84e5-35424611404a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ErythromycinERYTHROMYCINPD-Rx Pharmaceuticals, Inc.e54d66fa-93bb-4339-a75e-194a2e4488aa2025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061621
application number: ANDA061621
ErythromycinERYTHROMYCINWilshire Pharmaceuticalsf2efbc94-64f7-4130-ab23-e5983854f7302019-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061621
application number: ANDA061621
ErythromycinERYTHROMYCINArbor Pharmaceuticals, Inc.ca1326d6-c5c6-4572-96b6-e56cd944799c2018-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061621
application number: ANDA061621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-025-04552890025044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-025-04) 2012-05-040000-00-00NoNoCurrent