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 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 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.
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 2026-08-01 22:54:32 2026-06 A203584-001 CLARITHROMYCIN 250MG TABLET / ORAL AB 2015-09-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A203584-002 CLARITHROMYCIN 500MG TABLET / ORAL AB 2015-09-28 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A203584-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A203584-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 5 matching rows.
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
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