Home NDC 0781-6023 Clarithromycin
Product NDC 0781-6023
11-digit product format 007816023
Labeler code 0781
Product ID 0781-6023_fcbab0c3-9fdb-40aa-9a17-e53f88a19bbc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clarithromycin
Dosage form FOR SUSPENSION
Route ORAL
Labeler Sandoz Inc
Application ANDA065283
Marketing category ANDA
Marketing start 2007-09-04
Substance CLARITHROMYCIN
Active strength 250 mg/5mL
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 A065283-002 CLARITHROMYCIN CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 A065283-003 CLARITHROMYCIN CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04
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 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL AB 2007-09-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL AB RS 2007-09-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL AB 2007-09-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL AB RS 2007-09-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL AB 2007-09-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL AB RS 2007-09-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL AB 2007-09-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL AB RS 2007-09-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL AB 2007-09-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL AB RS 2007-09-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL AB 2007-09-04 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL AB RS 2007-09-04 782e0a99824c…
Observed Orange Book normalized TE history# 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 · 2 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 250 mg/5mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240741 Internal RxNorm lookup 309322 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 0781-6023-46 Clarithromycin 100 mL in 1 BOTTLE FOR SUSPENSION 100 15 0781-6023-52 Clarithromycin 50 mL in 1 BOTTLE FOR SUSPENSION 50 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLARITHROMYCIN ACTIVE INGREDIENT H1250JIK0A CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 CLARITHROMYCIN ACTIVE MOIETY H1250JIK0A CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 POVIDONES INACTIVE INGREDIENT FZ989GH94E CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 SUCROSE INACTIVE INGREDIENT C151H8M554 CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 9 CLARITHROMYCIN ACTIVE INGREDIENT H1250JIK0A CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 7 CLARITHROMYCIN ACTIVE MOIETY H1250JIK0A CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 7 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 7 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 7 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 7 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 7 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 7 POVIDONE INACTIVE INGREDIENT FZ989GH94E CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 7 SUCROSE INACTIVE INGREDIENT C151H8M554 CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 7 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 7 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-6023 CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] 15 Current NDC, Legacy NDC, 2 package rows 20231102_22457862-0f88-4be8-b507-1c8f264269f2.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-6023-46 00781602346 100 mL in 1 BOTTLE (0781-6023-46) 100 ml 2007-09-04 0000-00-00 No No Current 0781-6023-52 00781602352 50 mL in 1 BOTTLE (0781-6023-52) 50 ml 2007-09-04 0000-00-00 No No Current