Home NDC 71656-030 erythromycin topical solution 2%
Product NDC 71656-030
11-digit product format 716560030
Labeler code 71656
Product ID 71656-030_21b6729d-f82f-309a-e063-6394a90a8a36
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name erythromycin topical solution 2%
Dosage form SOLUTION
Route TOPICAL
Labeler Saptalis Pharmaceuticals, LLC LLC
Application ANDA062687
Marketing category ANDA
Marketing start 2024-08-14
Substance ERYTHROMYCIN
Active strength 20 mg/mL
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 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 A062687-001 ERYTHRA-DERM ERYTHROMYCIN 2% SOLUTION / TOPICAL AT 1988-02-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062687-001 AT
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 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL 1988-02-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL 1988-02-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL 1988-02-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL 1988-02-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL 1988-02-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL 1988-02-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL 1988-02-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL 1988-02-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062687-001 ERYTHRA-DERM 2% SOLUTION / TOPICAL AT 1988-02-05 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base erythromycin topical solution 2%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERYTHROMYCIN 20 mg/mL
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 318202 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71656-030-60 erythromycin topical solution 2% 1 in 1 CARTON SOLUTION 1 2 71656-030-60 erythromycin topical solution 2% 60 mL in 1 BOTTLE SOLUTION 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71656-030 ERYTHROMYCIN TOPICAL SOLUTION 2% SOLUTION [SAPTALIS PHARMACEUTICALS, LLC LLC] 2 Current NDC, 2 package rows 20240910_21b64a3f-2c95-1c1a-e063-6294a90a0ea0.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71656-030-60 71656003060 1 BOTTLE in 1 CARTON (71656-030-60) / 60 mL in 1 BOTTLE 1 bottle 2024-08-14 No No Current