Home NDC 0093-7528 Clarithromycin
Product NDC 0093-7528
11-digit product format 000937528
Labeler code 0093
Product ID 0093-7528_af1fac78-0f40-45e4-a26c-4bcdfb790126
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clarithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA065155
Marketing category ANDA
Marketing start 2014-12-16
Marketing end 0000-00-00
Substance CLARITHROMYCIN
Active strength 250 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 2020-12-31
Current FDA listing Historical FDA.report record 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 A065155-001 CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET / ORAL 2005-05-31 A065155-002 CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET / ORAL 2005-05-31
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 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL 2005-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL 2005-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL 2005-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL 2005-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL 2005-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL 2005-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL 2005-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL 2005-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL 2005-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL 2005-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL 2005-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL 2005-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL 2005-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL 2005-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL 2005-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL 2005-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL 2005-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL 2005-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL 2005-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL 2005-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL 2005-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL 2005-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL 2005-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL 2005-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL 2005-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL 2005-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL 2005-05-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL 2005-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2005-05-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2005-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2005-05-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2005-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2005-05-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2005-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2005-05-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2005-05-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2005-05-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2005-05-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065155-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2005-05-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065155-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2005-05-31 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLARITHROMYCIN ACTIVE INGREDIENT H1250JIK0A CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 CLARITHROMYCIN ACTIVE MOIETY H1250JIK0A CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 MAGNESIUM HYDROXIDE INACTIVE INGREDIENT NBZ3QY004S CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2 VANILLIN INACTIVE INGREDIENT CHI530446X CLARITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 2