Home NDC 63304-725 Clarithromycin
Product NDC 63304-725
11-digit product format 633040725
Labeler code 63304
Product ID 63304-725_1cf704dd-e3e3-4ae6-9b3e-f67116212adc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clarithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ranbaxy Pharmaceuticals Inc.
Application ANDA065174
Marketing category ANDA
Marketing start 2005-05-25
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 E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 3 · 132 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A065174-001 CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 A065174-002 CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24
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 · 86 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 2026-09-14 22:38:34 2026-08 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065174-001 CLARITHROMYCIN 250MG TABLET / ORAL 2004-09-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065174-002 CLARITHROMYCIN 500MG TABLET / ORAL 2004-09-24 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 63304-725-01 CLARITHROMYCIN TABLETS, USP AND CLARITHROMYCIN FOR ORAL SUSPENSION, USP Rx only 63304-725-05 CLARITHROMYCIN TABLETS, USP AND CLARITHROMYCIN FOR ORAL SUSPENSION, USP Rx only 63304-725-60 CLARITHROMYCIN TABLETS, USP AND CLARITHROMYCIN FOR ORAL SUSPENSION, USP Rx only 63304-725-77 CLARITHROMYCIN TABLETS, USP AND CLARITHROMYCIN FOR ORAL SUSPENSION, USP Rx only 63304-725-82 CLARITHROMYCIN TABLETS, USP AND CLARITHROMYCIN FOR ORAL SUSPENSION, USP Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63304-725-01 Clarithromycin 100 in 1 BOTTLE TABLET, FILM COATED 100 4 63304-725-05 Clarithromycin 500 in 1 BOTTLE TABLET, FILM COATED 500 4 63304-725-11 Clarithromycin 1 in 1 BLISTER PACK TABLET, FILM COATED 1 4 63304-725-60 Clarithromycin 60 in 1 BOTTLE TABLET, FILM COATED 60 4 63304-725-77 Clarithromycin 100 in 1 CARTON TABLET, FILM COATED 100 4 63304-725-82 Clarithromycin 12 in 1 BOTTLE TABLET, FILM COATED 12 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLARITHROMYCIN ACTIVE INGREDIENT H1250JIK0A CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 CLARITHROMYCIN ACTIVE MOIETY H1250JIK0A CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 ALGINIC ACID INACTIVE INGREDIENT 8C3Z4148WZ CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 CASTOR OIL INACTIVE INGREDIENT D5340Y2I9G CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) INACTIVE INGREDIENT 87Y6436BKR CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 POVIDONE INACTIVE INGREDIENT FZ989GH94E CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 SHELLAC INACTIVE INGREDIENT 46N107B71O CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-725 CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 4 Legacy NDC, 6 package rows 20131115_94c182ed-f2d6-4f7f-bdd9-69b136c54623.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 63304-725-01 63304072501 100 in 1 BOTTLE Historical 63304-725-05 63304072505 500 in 1 BOTTLE Historical 63304-725-11 63304072511 1 in 1 BLISTER PACK Historical 63304-725-60 63304072560 60 in 1 BOTTLE Historical 63304-725-77 63304072577 100 in 1 CARTON Historical 63304-725-82 63304072582 12 in 1 BOTTLE Historical