Clarithromycin

Product NDC: 0781-6022
11-digit product format: 007816022
Labeler code: 0781
Product ID: 0781-6022_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: 125 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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065283-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065283-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065283-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065283-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065283-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065283-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065283-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065283-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065283-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065283-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065283-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065283-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065283-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065283-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065283-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065283-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065283-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065283-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065283-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065283-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065283-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065283-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065283-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065283-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065283-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065283-003	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A065283-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065283-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065283-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065283-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065283-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065283-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065283-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A065283-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065283-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A065283-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065283-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065283-003	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clarithromycin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLARITHROMYCIN	125 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
22457862-0f88-4be8-b507-1c8f264269f2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2bb254ff-3d7f-4bdb-abf9-476506008c55	Product name	1	20230117
e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2	Product name	7	20221114
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0781-6022-46	Clarithromycin	100 mL in 1 BOTTLE	FOR SUSPENSION	100		15
0781-6022-52	Clarithromycin	50 mL in 1 BOTTLE	FOR SUSPENSION	50		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-6022-46	ML - Milliliter	0781-6022	9f793f36-cfc3-4cab-99a0-e0c5edacc4e5	1	2012-07-24
0781-6022-52	ML - Milliliter	0781-6022	f4a7141b-5c5e-40a7-8fba-809915931bc8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-6022	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	fad1e5a3-59f9-4868-9937-d3b061ab8f00	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065283 application number: ANDA065283
Clarithromycin	CLARITHROMYCIN	Sandoz Inc	22457862-0f88-4be8-b507-1c8f264269f2	2023-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065283 application number: ANDA065283 ndc (product): 0781-6022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H1250JIK0A	CLARITHROMYCIN	81103-11-9	CLARITHROMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
240741	clarithromycin 125 MG in 5 mL Oral Suspension	PSN	22457862-0f88-4be8-b507-1c8f264269f2	15
309322	clarithromycin 250 MG in 5 mL Oral Suspension	PSN	22457862-0f88-4be8-b507-1c8f264269f2	15
240741	clarithromycin 25 MG/ML Oral Suspension	SCD	22457862-0f88-4be8-b507-1c8f264269f2	15
309322	clarithromycin 50 MG/ML Oral Suspension	SCD	22457862-0f88-4be8-b507-1c8f264269f2	15
240741	clarithromycin 125 MG per 5 ML Oral Suspension	SY	22457862-0f88-4be8-b507-1c8f264269f2	15
309322	clarithromycin 250 MG per 5 ML Oral Suspension	SY	22457862-0f88-4be8-b507-1c8f264269f2	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-6022-46	00781602246	100 mL in 1 BOTTLE (0781-6022-46)	100 ml	2007-09-04	0000-00-00	No	No	Current
0781-6022-52	00781602252	50 mL in 1 BOTTLE (0781-6022-52)	50 ml	2007-09-04	0000-00-00	No	No	Current