ERYTHROMYCIN

Product NDC
72189-036
11-digit product format
721890036
Labeler code
72189
Product ID
72189-036_946c6eff-715b-2ca2-e053-2a95a90a1904
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ERYTHROMYCIN
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Direct_Rx
Application
ANDA062447
Marketing category
ANDA
Marketing start
2019-10-08
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#

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 productproduct72189-036IInactivated by FDA2026-08-17
excluded packagepackage72189-03672189-036-35IInactivated 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 packagepackage72189-036-35d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72189-036-35f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage72189-036-352ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage72189-036-35a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage72189-036-35cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage72189-036-35cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72189-036-35302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-036-35ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-036-350efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage72189-036-35ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage72189-036-35367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage72189-036-35557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage72189-036-358af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage72189-036-35834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage72189-036-351332a3947898…d4bfe170f9cd…

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

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
A062447-001ERYTHROMYCINERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-26

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMIC1983-09-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-263f01610625f2…
2019-09-15 20:21 UTC2019-09A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062447-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1983-09-26e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062447-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062447-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062447-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062447-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062447-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062447-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062447-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A062447-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062447-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062447-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062447-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A062447-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062447-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062447-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062447-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062447-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062447-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062447-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062447-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062447-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A062447-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A062447-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062447-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062447-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062447-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062447-001AT1cb3db0bc1861…

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
72189-036-352023-01-30C16284748780-1f386c64a-2990-0266-e053-dadaa90a7c1aERYTHROMYCIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-036-35ERYTHROMYCIN1 g in 1 TUBEOINTMENT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-036-35GM - Gram72189-0362d13ac89-54aa-4fa3-81e5-c86d358587fc12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-036ERYTHROMYCIN OINTMENT [DIRECT_RX]1Legacy NDC, 1 package rows20191010_946c6eff-715a-2ca2-e053-2a95a90a1904.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
erythromycinERYTHROMYCINNuCare Pharmaceuticals,Inc.84119a8f-78d1-2882-e053-2a91aa0a6faa2024-06-14Adverse reactionsExact identifier
application applno (ANDA): 062447
application number: ANDA062447
erythromycinERYTHROMYCINAsclemed USA, Inc.6186510d-62ca-4083-9895-8d028d71b5102023-09-12Adverse reactionsExact identifier
application applno (ANDA): 062447
application number: ANDA062447
erythromycinERYTHROMYCINA-S Medication Solutions1df12239-6957-4b2c-9e65-e2154eafddd02023-02-04Adverse reactionsExact identifier
application applno (ANDA): 062447
application number: ANDA062447

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN946c6eff-715a-2ca2-e053-2a95a90a19041
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD946c6eff-715a-2ca2-e053-2a95a90a19041
310149erythromycin 0.5 % Ophthalmic OintmentSY946c6eff-715a-2ca2-e053-2a95a90a19041
310149erythromycin 5 MG per GM Ophthalmic OintmentSY946c6eff-715a-2ca2-e053-2a95a90a19041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-036-35721890036351 g in 1 TUBE (72189-036-35) 1 g2019-10-080000-00-00NoNoCurrent