Erythromycin

Product NDC
53002-9050
Requested package NDC
53002-9050-1
11-digit product format
530029050
Labeler code
53002
Product ID
53002-9050_eac92fa7-f567-449a-8f11-f8b0b8908f8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
RPK Pharmaceuticals, Inc.
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
2021-12-31
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 packagepackage53002-905053002-9050-1IInactivated by FDA2026-08-03

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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-9050-1Erythromycin3.5 g in 1 TUBEOINTMENT3.55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-9050ERYTHROMYCIN OINTMENT [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_71d154c0-9a8c-446c-8826-3c6cd1249053.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN71d154c0-9a8c-446c-8826-3c6cd12490535
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD71d154c0-9a8c-446c-8826-3c6cd12490535
310149erythromycin 0.5 % Ophthalmic OintmentSY71d154c0-9a8c-446c-8826-3c6cd12490535
310149erythromycin 5 MG per GM Ophthalmic OintmentSY71d154c0-9a8c-446c-8826-3c6cd12490535

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9050-1530029050013.5 g in 1 TUBE (53002-9050-1) 3.5 g2017-10-010000-00-00NoNoCurrent