Erythromycin

Product NDC
55700-478
11-digit product format
557000478
Labeler code
55700
Product ID
55700-478_fee94a22-20db-4b97-84f4-364ed63558e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA064067
Marketing category
ANDA
Marketing start
1994-07-29
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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-478DDiscontinued by firm2026-08-03
excluded packagepackage55700-47855700-478-35DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 32 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct55700-478DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-47855700-478-35DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct55700-478DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-47855700-478-35DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct55700-478DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-47855700-478-35DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct55700-478DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-47855700-478-35DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct55700-478DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-47855700-478-35DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct55700-478DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-47855700-478-35DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct55700-478IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-47855700-478-35IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct55700-478IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-47855700-478-35IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct55700-478IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-47855700-478-35IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct55700-478IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55700-47855700-478-35IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct55700-478IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55700-47855700-478-35IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct55700-478IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55700-47855700-478-35IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproduct55700-478IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55700-47855700-478-35IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct55700-478IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55700-47855700-478-35IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproduct55700-478IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55700-47855700-478-35IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct55700-478IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55700-47855700-478-35IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…

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
A064067-001ERYTHROMYCINERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064067-001AT

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 UTC2026-02A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-293f01610625f2…
2019-09-15 20:21 UTC2019-09A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1994-07-29cb3db0bc1861…

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 UTC2026-02A064067-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064067-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064067-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064067-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064067-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064067-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064067-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064067-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064067-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064067-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064067-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064067-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064067-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064067-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064067-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064067-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064067-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064067-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064067-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064067-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064067-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A064067-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064067-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064067-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064067-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A064067-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064067-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064067-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064067-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064067-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064067-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064067-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064067-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064067-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A064067-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A064067-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064067-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064067-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064067-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064067-001AT1cb3db0bc1861…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ErythromycinERYTHROMYCINSportpharm LLC790d3e3e-df69-45f7-97d5-da65faa465562026-07-21Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINCardinal Health 107, LLCba4f06c3-ebce-4896-a5cc-59bb5c2cb4e52026-04-27Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINPreferred Pharmaceuticals, Inc.ee3d806e-65ce-42e1-b170-7b35bcb7b06a2026-04-10Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ERYTHROMYCINERYTHROMYCINDirect Rx9ac4dcd2-8cac-404d-b651-da74062d30ed2026-03-17Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINREMEDYREPACK INC.c49ad63b-c2fd-4535-bec0-6415c93cf8472026-01-09Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINA-S Medication Solutions2be16639-b153-407b-b43d-3a2bcf66151e2025-12-03Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINBausch & Lomb Incorporated061ddd20-94a6-4e3c-ba84-1ebd8529eea62025-04-22Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINNuCare Pharmaceuticals,Inc.5568ade8-bdc2-1a32-e054-00144ff8d46c2024-08-14Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINNuCare Pharmaceuticals,Inc.6296e2ed-334c-b9af-e053-2991aa0aae0c2024-06-06Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINProficient Rx LP5101bf55-cacf-42bf-8dd1-2a29e80ca6f12022-07-01Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINAsclemed USA, Inc.7810e881-5130-4a94-b2e0-9f63f8a7a5042021-11-30Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-478-35GM - Gram55700-4781e9cf999-7d50-4b2b-b438-24ab56ab08de12017-03-06