Home NDC 63187-376 Clarithromycin
Product NDC 63187-376
11-digit product format 631870376
Labeler code 63187
Product ID 63187-376_f6ee6e86-2078-4354-9def-3f94fc7b6a6c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clarithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA203584
Marketing category ANDA
Marketing start 2015-12-04
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 A203584-001 CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 A203584-002 CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28
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 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 63187-376-14 Clarithromycin 14 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 14 6 63187-376-20 Clarithromycin 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 6 63187-376-28 Clarithromycin 28 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 28 6 63187-376-30 Clarithromycin 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 6 63187-376-60 Clarithromycin 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 6 63187-376-90 Clarithromycin 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-376 CLARITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] 5 Current NDC, Legacy NDC, 6 package rows 20220710_9eb306e0-ccfb-418c-82ca-204f20a788f7.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 · 5 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 63187-376-14 63187037614 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-14) 2025-11-07 No No Current 63187-376-20 63187037620 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-20) 2021-12-29 0000-00-00 No No Current 63187-376-28 63187037628 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-28) 2016-09-01 0000-00-00 No No Current 63187-376-30 63187037630 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-30) 2016-09-01 0000-00-00 No No Current 63187-376-60 63187037660 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-60) 2016-09-01 0000-00-00 No No Current 63187-376-90 63187037690 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-376-90) 2021-12-29 0000-00-00 No No Current