Home NDC 85766-197 Clarithromycin
Product NDC 85766-197
11-digit product format 857660197
Labeler code 85766
Product ID 85766-197_4fa17015-6060-4973-e063-6394a90a798d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clarithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sportpharm LLC
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 2027-12-31
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.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Clarithromycin
Listing expiration 2027-12-31 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 85766-197-01 Clarithromycin 100 in 1 BOTTLE TABLET, FILM COATED 100 1 85766-197-05 Clarithromycin 5 in 1 BOTTLE TABLET, FILM COATED 5 1 85766-197-07 Clarithromycin 7 in 1 BOTTLE TABLET, FILM COATED 7 1 85766-197-10 Clarithromycin 10 in 1 BOTTLE TABLET, FILM COATED 10 1 85766-197-15 Clarithromycin 15 in 1 BOTTLE TABLET, FILM COATED 15 1 85766-197-20 Clarithromycin 20 in 1 BOTTLE TABLET, FILM COATED 20 1 85766-197-30 Clarithromycin 30 in 1 BOTTLE TABLET, FILM COATED 30 1 85766-197-60 Clarithromycin 60 in 1 BOTTLE TABLET, FILM COATED 60 1 85766-197-90 Clarithromycin 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 85766-197-01 85766019701 100 TABLET, FILM COATED in 1 BOTTLE (85766-197-01) 2026-04-17 No No Current 85766-197-05 85766019705 5 TABLET, FILM COATED in 1 BOTTLE (85766-197-05) 2026-04-17 No No Current 85766-197-07 85766019707 7 TABLET, FILM COATED in 1 BOTTLE (85766-197-07) 2026-04-17 No No Current 85766-197-10 85766019710 10 TABLET, FILM COATED in 1 BOTTLE (85766-197-10) 2026-04-17 No No Current 85766-197-15 85766019715 15 TABLET, FILM COATED in 1 BOTTLE (85766-197-15) 2026-04-17 No No Current 85766-197-20 85766019720 20 TABLET, FILM COATED in 1 BOTTLE (85766-197-20) 2026-04-17 No No Current 85766-197-30 85766019730 30 TABLET, FILM COATED in 1 BOTTLE (85766-197-30) 2026-04-17 No No Current 85766-197-60 85766019760 60 TABLET, FILM COATED in 1 BOTTLE (85766-197-60) 2026-04-17 No No Current 85766-197-90 85766019790 90 TABLET, FILM COATED in 1 BOTTLE (85766-197-90) 2026-04-17 No No Current