Albendazole

Product NDC: 78482-110
Requested package NDC: 78482-110-02
11-digit product format: 784820110
Labeler code: 78482
Product ID: 78482-110_064c86bf-5d4d-4200-97fc-8ee09cabf000
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Albendazole
Dosage form: TABLET
Route: ORAL
Labeler: Mark Cuban Cost Plus Drug Company, PBC
Application: ANDA211117
Marketing category: ANDA
Marketing start: 2020-08-19
Marketing end: 0000-00-00
Substance: ALBENDAZOLE
Active strength: 200 mg/1
Pharmacologic classes: Anthelmintic [EPC], Cytochrome P450 1A Inducers [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	78482-110	78482-110-02	I	Inactivated by FDA		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A211117-001	ALBENDAZOLE	ALBENDAZOLE	200MG	TABLET / ORAL	AB		2019-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211117-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211117-001	ALBENDAZOLE	200MG	TABLET / ORAL	AB	2019-05-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211117-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211117-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211117-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211117-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211117-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211117-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211117-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211117-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211117-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211117-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211117-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211117-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211117-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211117-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211117-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211117-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211117-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211117-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211117-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211117-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211117-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211117-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211117-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211117-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211117-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211117-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211117-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211117-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211117-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211117-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211117-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211117-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211117-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211117-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211117-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211117-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211117-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211117-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211117-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211117-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b0e27303-91cd-2fd1-e9ec-fbe22a3c3f49	Product name	8	20250325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78482-110-02	Albendazole	2 in 1 BOTTLE	TABLET	2		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
78482-110-02	EA - Each	78482-110	89c2f8e9-2a88-46b7-86ef-982489704fec	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78482-110	ALBENDAZOLE TABLET [MARK CUBAN COST PLUS DRUG COMPANY, PBC]	4	Legacy NDC, 1 package rows	20240117_852f013f-6759-4438-83c1-8ff48133dc85.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
Albendazole	ALBENDAZOLE	Edenbridge Pharmaceuticals LLC.	6c48fd89-cb40-477c-8a78-15cbe0df6faa	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211117 application number: ANDA211117
Albendazole	ALBENDAZOLE	Golden State Medical Supply, Inc.	8de337eb-92e1-15b5-e053-2a95a90ac4f1	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211117 application number: ANDA211117

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F4216019LN	ALBENDAZOLE	54965-21-8	ALBENDAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199672	albendazole 200 MG Oral Tablet	PSN	852f013f-6759-4438-83c1-8ff48133dc85	4
199672	albendazole 200 MG Oral Tablet	SCD	852f013f-6759-4438-83c1-8ff48133dc85	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78482-110-02	78482011002	2 TABLET in 1 BOTTLE (78482-110-02)	2 tablet	2020-08-19	0000-00-00	No	No	Current