Clarithromycin

Product NDC: 0781-1961
11-digit product format: 007811961
Labeler code: 0781
Product ID: 0781-1961_a18fa357-b294-48b9-aabe-dad7d6259ba3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clarithromycin
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA065144
Marketing category: ANDA
Marketing start: 2005-10-18
Substance: CLARITHROMYCIN
Active strength: 250 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	0781-1961	0781-1961-01	D	Discontinued by firm	2026-08-17
excluded package	package	0781-1961	0781-1961-10	D	Discontinued by firm	2026-08-17
excluded package	package	0781-1961	0781-1961-31	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0781-1961-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0781-1961-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0781-1961-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0781-1961-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0781-1961-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0781-1961-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0781-1961-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0781-1961-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0781-1961-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0781-1961-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0781-1961-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0781-1961-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0781-1961-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0781-1961-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0781-1961-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0781-1961-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0781-1961-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0781-1961-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0781-1961-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0781-1961-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0781-1961-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0781-1961-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0781-1961-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0781-1961-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0781-1961-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0781-1961-31	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0781-1961-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0781-1961-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0781-1961-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0781-1961-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0781-1961-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0781-1961-31	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0781-1961-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0781-1961-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0781-1961-31	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0781-1961-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065144-001	CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET / ORAL	AB		2005-10-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A065144-001	AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065144-001	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2005-10-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065144-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065144-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065144-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065144-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065144-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065144-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065144-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065144-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065144-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065144-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065144-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065144-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065144-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065144-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065144-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065144-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065144-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065144-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065144-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065144-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065144-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065144-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065144-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065144-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065144-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065144-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065144-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065144-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065144-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065144-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065144-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065144-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065144-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065144-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065144-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065144-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065144-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065144-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065144-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065144-001	AB	1	`e64feba35796…`

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/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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197516	Internal RxNorm lookup
197517	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
b98b02bb-2609-49a0-b29f-e5911aa0cbc1	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	SPL version
0781-1961-01	Clarithromycin	100 in 1 BOTTLE	TABLET	100	23
0781-1961-10	Clarithromycin	1000 in 1 BOTTLE	TABLET	1000	23
0781-1961-31	Clarithromycin	30 in 1 BOTTLE	TABLET	30	23
0781-1961-60	Clarithromycin	60 in 1 BOTTLE	TABLET	60	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-1961-60	EA - Each	0781-1961	7b7bb0aa-65e8-4f77-9744-f7621a19e124	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLARITHROMYCIN	ACTIVE INGREDIENT	H1250JIK0A	CLARITHROMYCIN TABLET [SANDOZ INC]	15
CLARITHROMYCIN	ACTIVE MOIETY	H1250JIK0A	CLARITHROMYCIN TABLET [SANDOZ INC]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLARITHROMYCIN TABLET [SANDOZ INC]	15
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CLARITHROMYCIN TABLET [SANDOZ INC]	15
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	CLARITHROMYCIN TABLET [SANDOZ INC]	15
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CLARITHROMYCIN TABLET [SANDOZ INC]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLARITHROMYCIN TABLET [SANDOZ INC]	15
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CLARITHROMYCIN TABLET [SANDOZ INC]	15
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CLARITHROMYCIN TABLET [SANDOZ INC]	15
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CLARITHROMYCIN TABLET [SANDOZ INC]	15
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CLARITHROMYCIN TABLET [SANDOZ INC]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLARITHROMYCIN TABLET [SANDOZ INC]	15
clarithromycin	ACTIVE INGREDIENT	H1250JIK0A	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
clarithromycin	ACTIVE MOIETY	H1250JIK0A	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-1961	CLARITHROMYCIN TABLET [SANDOZ INC]	23	Current NDC, Legacy NDC, 4 package rows	20231102_b98b02bb-2609-49a0-b29f-e5911aa0cbc1.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	Sandoz Inc	b98b02bb-2609-49a0-b29f-e5911aa0cbc1	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065144 application number: ANDA065144 ndc (product): 0781-1961

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
197516	clarithromycin 250 MG Oral Tablet	PSN	b98b02bb-2609-49a0-b29f-e5911aa0cbc1	23
197517	clarithromycin 500 MG Oral Tablet	PSN	b98b02bb-2609-49a0-b29f-e5911aa0cbc1	23
197516	clarithromycin 250 MG Oral Tablet	SCD	b98b02bb-2609-49a0-b29f-e5911aa0cbc1	23
197517	clarithromycin 500 MG Oral Tablet	SCD	b98b02bb-2609-49a0-b29f-e5911aa0cbc1	23
197516	clarithromycin 250 MG Oral Tablet	PSN	f3a50f13-b028-4135-8f20-bfb62a9bc0a9	1
197517	clarithromycin 500 MG Oral Tablet	PSN	f3a50f13-b028-4135-8f20-bfb62a9bc0a9	1
197516	clarithromycin 250 MG Oral Tablet	SCD	f3a50f13-b028-4135-8f20-bfb62a9bc0a9	1
197517	clarithromycin 500 MG Oral Tablet	SCD	f3a50f13-b028-4135-8f20-bfb62a9bc0a9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-1961-01	00781196101	100 in 1 BOTTLE						Historical
0781-1961-10	00781196110	1000 in 1 BOTTLE						Historical
0781-1961-31	00781196131	30 in 1 BOTTLE						Historical
0781-1961-60	00781196160	60 TABLET in 1 BOTTLE (0781-1961-60)	60 tablet	2005-10-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clarithromycin	Sandoz Inc	2023-05-30	HUMAN PRESCRIPTION DRUG LABEL	23
Clarithromycin	A-S Medication Solutions	2023-02-06	HUMAN PRESCRIPTION DRUG LABEL	3
Clarithromycin Tablets, USP	Rebel Distributors Corp.	2010-09-15	HUMAN PRESCRIPTION DRUG LABEL	1