Home NDC 0054-0037 Clarithromycin
Product NDC 0054-0037
11-digit product format 000540037
Labeler code 0054
Product ID 0054-0037_4fa22138-ea75-4959-96c8-b432b2162c0e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clarithromycin
Dosage form TABLET, COATED
Route ORAL
Labeler West-Ward Pharmaceuticals Corp.
Application ANDA065178
Marketing category ANDA
Marketing start 2004-05-25
Marketing end 2020-07-05
Substance CLARITHROMYCIN
Active strength 500 mg/1
Pharmacologic classes Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 10 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 0054-0037 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0054-0037 0054-0037-21 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0054-0037 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0054-0037 0054-0037-21 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product 0054-0037 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0054-0037 0054-0037-21 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 0054-0037 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0054-0037 0054-0037-21 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 0054-0037 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0054-0037 0054-0037-21 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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 A065178-001 CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 A065178-002 CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25
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 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL AB 2004-05-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL AB 2004-05-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065178-001 CLARITHROMYCIN 500MG TABLET / ORAL 2004-05-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065178-002 CLARITHROMYCIN 250MG TABLET / ORAL 2004-05-25 782e0a99824c…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLARITHROMYCIN ACTIVE INGREDIENT H1250JIK0A CLARITHROMYCIN TABLET, COATED [BRYANT RANCH PREPACK] 1000 CLARITHROMYCIN ACTIVE MOIETY H1250JIK0A CLARITHROMYCIN TABLET, COATED [BRYANT RANCH PREPACK] 1000 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLARITHROMYCIN TABLET, COATED [BRYANT RANCH PREPACK] 1000 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CLARITHROMYCIN TABLET, COATED [BRYANT RANCH PREPACK] 1000 HYPROMELLOSE 2208 (100 MPA.S) INACTIVE INGREDIENT B1QE5P712K CLARITHROMYCIN TABLET, COATED [BRYANT RANCH PREPACK] 1000 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLARITHROMYCIN TABLET, COATED [BRYANT RANCH PREPACK] 1000 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLARITHROMYCIN TABLET, COATED [BRYANT RANCH PREPACK] 1000 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE CLARITHROMYCIN TABLET, COATED [BRYANT RANCH PREPACK] 1000 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CLARITHROMYCIN TABLET, COATED [BRYANT RANCH PREPACK] 1000 POVIDONES INACTIVE INGREDIENT FZ989GH94E CLARITHROMYCIN TABLET, COATED [BRYANT RANCH PREPACK] 1000 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP CLARITHROMYCIN TABLET, COATED [BRYANT RANCH PREPACK] 1000 TALC INACTIVE INGREDIENT 7SEV7J4R1U CLARITHROMYCIN TABLET, COATED [BRYANT RANCH PREPACK] 1000 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLARITHROMYCIN TABLET, COATED [BRYANT RANCH PREPACK] 1000 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 CLARITHROMYCIN TABLET, COATED [BRYANT RANCH PREPACK] 1000 CLARITHROMYCIN ACTIVE INGREDIENT H1250JIK0A CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC] 13 CLARITHROMYCIN ACTIVE MOIETY H1250JIK0A CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC] 13 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC] 13 HYPROMELLOSE 2208 (100 MPA.S) INACTIVE INGREDIENT B1QE5P712K CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC] 13 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC] 13 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC] 13 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC] 13 POVIDONES INACTIVE INGREDIENT FZ989GH94E CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC] 13 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC] 13 TALC INACTIVE INGREDIENT 7SEV7J4R1U CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC] 13 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 CLARITHROMYCIN TABLET, COATED [ROXANE LABORATORIES, INC] 13
DailyMed RxNorm Mappings#