Erythromycin

Product NDC
55700-151
11-digit product format
557000151
Labeler code
55700
Product ID
55700-151_c0b9c729-6060-4378-932b-bbc721d7d2ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Lake Erie Medical DBA Quality Caer Products LLC
Application
ANDA064030
Marketing category
ANDA
Marketing start
1996-07-18
Marketing end
0000-00-00
Substance
ERYTHROMYCIN
Active strength
5 mg/g
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct55700-151DDiscontinued by firm2026-08-10
excluded packagepackage55700-15155700-151-35DDiscontinued by firm2026-08-10

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-151-35DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-151-35DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-151-35DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-151-35DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-151-35DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-151-35DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-151-35DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-151-35DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-151-35DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-151-35DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-151-35DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-151-35DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55700-151-35EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A064030-001ERYTHROMYCINERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064030-001AT

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-183f01610625f2…
2019-09-15 20:21 UTC2019-09A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A064030-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064030-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064030-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064030-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064030-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064030-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064030-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064030-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064030-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064030-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064030-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064030-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064030-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064030-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064030-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064030-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064030-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064030-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064030-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064030-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064030-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A064030-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064030-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064030-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064030-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A064030-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064030-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064030-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064030-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064030-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064030-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064030-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064030-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064030-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A064030-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A064030-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064030-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064030-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064030-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064030-001AT1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-151-35GM - Gram55700-15175264099-0065-48ba-8e83-93f2ec54507512016-12-07

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ErythromycinERYTHROMYCINNuCare Pharmaceuticals,Inc.50c8d6b3-4660-e829-e063-6294a90a919b2026-05-01Adverse reactionsExact identifier
application applno (ANDA): 064030
application number: ANDA064030
ErythromycinERYTHROMYCINSentiss Pharmaceuticals LLC4da0e351-383f-55da-e063-6394a90a8eba2026-03-31Adverse reactionsExact identifier
application applno (ANDA): 064030
application number: ANDA064030
ErythromycinERYTHROMYCINRedpharm Drug301ee5ad-3b6c-1152-e063-6294a90a54e72025-12-23Adverse reactionsExact identifier
application applno (ANDA): 064030
application number: ANDA064030
ErythromycinERYTHROMYCINST. MARY'S MEDICAL PARK PHARMACY2cc726c2-3746-6dbf-e063-6294a90a789f2025-01-28Adverse reactionsExact identifier
application applno (ANDA): 064030
application number: ANDA064030
ErythromycinERYTHROMYCINARMAS PHARMACEUTICALS INC.07fdeac5-f690-d74b-e063-6394a90a5c5b2023-10-23Adverse reactionsExact identifier
application applno (ANDA): 064030
application number: ANDA064030
ErythromycinERYTHROMYCINProficient Rx LP62896bec-669e-4f20-a1e4-4f99afd35d322022-04-01Adverse reactionsExact identifier
application applno (ANDA): 064030
application number: ANDA064030
ErythromycinERYTHROMYCINAsclemed USA, Inc.bccdb8f3-b5f5-4f07-8ddb-8811d5c1b73c2022-03-07Adverse reactionsExact identifier
application applno (ANDA): 064030
application number: ANDA064030