Home NDC 70771-1548 Erythromycin
Product NDC 70771-1548
11-digit product format 707711548
Labeler code 70771
Product ID 70771-1548_35a32479-429b-4e71-9c5c-1e8ddbdff5e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Erythromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA212693
Marketing category ANDA
Marketing start 2023-06-30
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A212693-001 ERYTHROMYCIN ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 A212693-002 ERYTHROMYCIN ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07
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 · 46 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 2026-02-19 14:30 UTC 2026-02 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212693-001 ERYTHROMYCIN 250MG TABLET / ORAL AB 2023-03-07 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212693-002 ERYTHROMYCIN 500MG TABLET / ORAL AB 2023-03-07 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 46 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Erythromycin
Listing expiration 2026-12-31 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 70771-1548-1 Erythromycin 100 in 1 BOTTLE TABLET, FILM COATED 100 2 70771-1548-3 Erythromycin 30 in 1 BOTTLE TABLET, FILM COATED 30 2 70771-1548-5 Erythromycin 500 in 1 BOTTLE TABLET, FILM COATED 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1548 ERYTHROMYCIN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 2 Current NDC, 3 package rows 20230630_76608fdd-1248-4942-9518-fd8076244fa7.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 Sample Exclude flag Status 70771-1548-1 70771154801 100 TABLET, FILM COATED in 1 BOTTLE (70771-1548-1) 2023-06-30 No No Current 70771-1548-3 70771154803 30 TABLET, FILM COATED in 1 BOTTLE (70771-1548-3) 2023-06-30 No No Current 70771-1548-5 70771154805 500 TABLET, FILM COATED in 1 BOTTLE (70771-1548-5) 2023-06-30 No No Current