Home NDC 46708-344 Clarithromycin
Product NDC 46708-344
11-digit product format 467080344
Labeler code 46708
Product ID 46708-344_17817dba-4183-4a14-a55f-3e1240ea03a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clarithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA210459
Marketing category ANDA
Marketing start 2022-02-01
Substance CLARITHROMYCIN
Active strength 250 mg/1
Pharmacologic classes Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]
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 A210459-001 CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 A210459-002 CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31
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 · 64 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 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210459-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2022-01-31 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A210459-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2022-01-31 1c564ffb4f44…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clarithromycin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLARITHROMYCIN 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H1250JIK0A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197516 Internal RxNorm lookup 197517 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 46708-344-30 Clarithromycin 30 in 1 BOTTLE TABLET, FILM COATED 30 3 46708-344-60 Clarithromycin 60 in 1 BOTTLE TABLET, FILM COATED 60 3 46708-344-91 Clarithromycin 1000 in 1 BOTTLE TABLET, FILM COATED 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-344 CLARITHROMYCIN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 3 Current NDC, 3 package rows 20230531_268d21f9-02c9-41b0-9487-7968ea12720d.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 Marketing start Sample Exclude flag Status 46708-344-30 46708034430 30 TABLET, FILM COATED in 1 BOTTLE (46708-344-30) 2022-02-01 No No Current 46708-344-60 46708034460 60 TABLET, FILM COATED in 1 BOTTLE (46708-344-60) 2022-02-01 No No Current 46708-344-91 46708034491 1000 TABLET, FILM COATED in 1 BOTTLE (46708-344-91) 2022-02-01 No No Current