Home NDC 13668-606 Erythromycin
Product NDC 13668-606
11-digit product format 136680606
Labeler code 13668
Product ID 13668-606_be7fded9-0e2a-4b0e-b668-7be090de7919
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Erythromycin
Dosage form TABLET, COATED
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA212015
Marketing category ANDA
Marketing start 2020-07-06
Substance ERYTHROMYCIN
Active strength 250 mg/1
Pharmacologic classes Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212015-001 ERYTHROMYCIN ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 A212015-002 ERYTHROMYCIN ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 76 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 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212015-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2020-07-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212015-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2020-07-06 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Erythromycin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERYTHROMYCIN 250 mg/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197650 Internal RxNorm lookup 598006 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 13668-606-01 Erythromycin 100 in 1 BOTTLE TABLET, COATED 100 11 13668-606-05 Erythromycin 500 in 1 BOTTLE TABLET, COATED 500 11 13668-606-30 Erythromycin 30 in 1 BOTTLE TABLET, COATED 30 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-606 ERYTHROMYCIN TABLET, COATED [TORRENT PHARMACEUTICALS LIMITED] 10 Current NDC, Legacy NDC, 3 package rows 20241025_933049f6-61b9-4ed5-b6b7-60c5037e2115.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 13668-606-01 13668060601 100 TABLET, COATED in 1 BOTTLE (13668-606-01) 2020-07-06 0000-00-00 No No Current 13668-606-05 13668060605 500 TABLET, COATED in 1 BOTTLE (13668-606-05) 2020-07-07 0000-00-00 No No Current 13668-606-30 13668060630 30 TABLET, COATED in 1 BOTTLE (13668-606-30) 2022-04-12 0000-00-00 No No Current