Home NDC 62135-615 CLARITHROMYCIN
Product NDC 62135-615
11-digit product format 621350615
Labeler code 62135
Product ID 62135-615_f08573c8-02d4-3717-e053-2a95a90a2dda
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clarithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chartwell RX, LLC.
Application ANDA065384
Marketing category ANDA
Marketing start 2007-08-20
Substance CLARITHROMYCIN
Active strength 500 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 A065384-001 CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 A065384-002 CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20
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 3 · 82 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 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065384-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2007-08-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065384-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2007-08-20 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base CLARITHROMYCIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLARITHROMYCIN 500 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 62135-615-60 CLARITHROMYCIN 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-615 CLARITHROMYCIN TABLET, FILM COATED [CHARTWELL RX, LLC.] 2 Current NDC, Legacy NDC, 1 package rows 20221224_99d2fd6b-39ca-42f9-ad06-30e7fbc22c47.zip
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 62135-615-60 62135061560 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-615-60) 2021-02-01 0000-00-00 No No Current