Home NDC 68071-4803 erythromycin
Product NDC 68071-4803
11-digit product format 680714803
Labeler code 68071
Product ID 68071-4803_1adc6bbc-3f85-b36b-e063-6294a90a6c27
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name erythromycin
Dosage form OINTMENT
Route OPHTHALMIC
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA062447
Marketing category ANDA
Marketing start 2014-05-08
Substance ERYTHROMYCIN
Active strength 5 mg/g
Pharmacologic classes Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4803-3 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4803-3 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4803-3 1332a3947898…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A062447-001 ERYTHROMYCIN ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC 1983-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062447-001 ERYTHROMYCIN 0.5% OINTMENT / OPHTHALMIC AT RS 1983-09-26 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base erythromycin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERYTHROMYCIN 5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 63937KV33D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310149 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4803-3 erythromycin 3.5 g in 1 BOX OINTMENT 3.5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4803 ERYTHROMYCIN OINTMENT [NUCARE PHARMACEUTICALS,INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240616_84119a8f-78d1-2882-e053-2a91aa0a6faa.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-4803-3 68071480303 3.5 g in 1 BOX (68071-4803-3) 3.5 g 2019-03-14 0000-00-00 No No Current