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 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 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 · 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 A065283-002 CLARITHROMYCIN 125MG/5ML FOR SUSPENSION / ORAL 2007-09-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065283-003 CLARITHROMYCIN 250MG/5ML FOR SUSPENSION / ORAL RS 2007-09-04 caaa826d4ba7…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…
Observed Orange Book normalized TE history# 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
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 · 2 matching rows.
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