Home NDC 0378-8212 Erythromycin
Product NDC 0378-8212
11-digit product format 003788212
Labeler code 0378
Product ID 0378-8212_09b16a2d-825a-4d08-b86e-076548926916
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name erythromycin
Dosage form GEL
Route TOPICAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA050617
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-10-19
Marketing end 0000-00-00
Substance ERYTHROMYCIN
Active strength 20 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 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 0378-8212 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0378-8212 0378-8212-60 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0378-8212 0378-8212-93 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 N050617-001 ERYGEL ERYTHROMYCIN 2% GEL / TOPICAL RLD 1987-10-21
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 N050617-001 ERYGEL 2% GEL / TOPICAL RLD 1987-10-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050617-001 ERYGEL 2% GEL / TOPICAL RLD 1987-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050617-001 ERYGEL 2% GEL / TOPICAL RLD 1987-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050617-001 ERYGEL 2% GEL / TOPICAL AT RLD, RS 1987-10-21 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-8212 ERYTHROMYCIN GEL [MYLAN PHARMACEUTICALS INC.] 2 Legacy NDC 20250214_09b16a2d-825a-4d08-b86e-076548926916.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-8212-60 00378821260 1 TUBE in 1 CARTON (0378-8212-60) > 60 g in 1 TUBE 1 tube 2018-10-19 0000-00-00 No No Current 0378-8212-93 00378821293 1 TUBE in 1 CARTON (0378-8212-93) > 30 g in 1 TUBE 1 tube 2018-10-19 0000-00-00 No No Current