Home NDC 43063-752 Clarithromycin
Product NDC 43063-752
11-digit product format 430630752
Labeler code 43063
Product ID 43063-752_414b6e4d-1cbe-49be-e063-6294a90ad88f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clarithromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA203584
Marketing category ANDA
Marketing start 2019-11-23
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 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 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 · 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 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 43063-752-14 Clarithromycin 14 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 14 23 43063-752-20 Clarithromycin 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 23 43063-752-28 Clarithromycin 28 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 28 23
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-752 CLARITHROMYCIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 22 Current NDC, Legacy NDC, 3 package rows 20240608_1cb8a78a-0f07-49e8-a23e-a77628006209.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 43063-752-14 43063075214 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-752-14) 2019-11-23 0000-00-00 No No Current 43063-752-20 43063075220 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-752-20) 2019-11-23 0000-00-00 No No Current 43063-752-28 43063075228 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-752-28) 2019-11-23 0000-00-00 No No Current