Home NDC 33261-618 Clarithromycin
Product NDC 33261-618
11-digit product format 332610618
Labeler code 33261
Product ID 33261-618_c32a755e-ce62-4ae6-a581-e1f2f26e65ed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clarithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aidarex Pharmaceuticals LLC
Application ANDA065266
Marketing category ANDA
Marketing start 2006-05-31
Marketing end 0000-00-00
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 2019-12-31
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 2 · 84 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A065266-001 CLARITHROMYCIN CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 A065266-002 CLARITHROMYCIN CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31
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 · 84 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 2026-08-18 06:07:40 2026-07 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2006-05-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2006-05-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065266-001 CLARITHROMYCIN 250MG TABLET / ORAL 2006-05-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065266-002 CLARITHROMYCIN 500MG TABLET / ORAL 2006-05-31 bb7c543d1eb4…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33261-618-10 Clarithromycin 10 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 10 1 33261-618-14 Clarithromycin 14 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 14 1 33261-618-20 Clarithromycin 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLARITHROMYCIN ACTIVE INGREDIENT H1250JIK0A CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CLARITHROMYCIN ACTIVE MOIETY H1250JIK0A CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33261-618 CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 Legacy NDC, 3 package rows 20140102_b333961e-22af-41de-9fad-192d56af8d38.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 33261-618-10 33261061810 10 in 1 BOTTLE, PLASTIC Historical 33261-618-14 33261061814 14 in 1 BOTTLE, PLASTIC Historical 33261-618-20 33261061820 20 in 1 BOTTLE, PLASTIC Historical