Application 090678

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	TABLET, DELAYED RELEASE;ORAL	20MG	No	No

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
A090678-001	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB		2013-11-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090678-001	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	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`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	A090678-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090678-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090678-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090678-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090678-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090678-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090678-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090678-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090678-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090678-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090678-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090678-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090678-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090678-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090678-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090678-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090678-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090678-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090678-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090678-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090678-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090678-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090678-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090678-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090678-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090678-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090678-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090678-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090678-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090678-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090678-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090678-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090678-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090678-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090678-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090678-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090678-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090678-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090678-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090678-001	AB	1	`e64feba35796…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Chartwell RX, LLC	c5c43222-d167-4152-b5c7-84b55920a7ce	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090678 application number: ANDA090678
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Proficient Rx LP	14412af6-e99c-4264-bc34-28a6f139f252	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090678 application number: ANDA090678 ndc (product): 63187-259
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Golden State Medical Supply, Inc.	87231460-8b1e-b995-e053-2a91aa0a6c43	2024-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090678 application number: ANDA090678 ndc (product): 51407-184
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	e6350638-99b0-474d-be75-ae2a3e1af2cf	2023-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090678 application number: ANDA090678 ndc (product): 71335-0244
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Lannett Company, Inc.	7f7d68f0-972b-4315-b712-0bb8a84c85cc	2023-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090678 application number: ANDA090678 ndc (product): 62175-302

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-722	Rabeprazole Sodium	Rabeprazole Sodium	AvKARE, Inc.	ANDA	Current
50090-3145	Rabeprazole Sodium	Rabeprazole Sodium	A-S Medication Solutions	ANDA	Current
50090-3145	Rabeprazole Sodium	Rabeprazole Sodium	A-S Medication Solutions	ANDA	Current
50090-3145	Rabeprazole Sodium	Rabeprazole Sodium	A-S Medication Solutions	ANDA	Current
50436-0302	Rabeprazole Sodium	Rabeprazole Sodium	Unit Dose Services	ANDA	Current
51407-184	Rabeprazole Sodium	Rabeprazole Sodium	Golden State Medical Supply Inc.	ANDA	Current
51407-184	Rabeprazole Sodium	Rabeprazole Sodium	Golden State Medical Supply Inc.	ANDA	Current
51407-184	Rabeprazole Sodium	Rabeprazole Sodium	Golden State Medical Supply Inc.	ANDA	Current
51407-184	Rabeprazole Sodium	Rabeprazole Sodium	Golden State Medical Supply, Inc.	ANDA	Current
51407-184	Rabeprazole Sodium	Rabeprazole Sodium	Golden State Medical Supply, Inc.	ANDA	Current
51407-184	Rabeprazole Sodium	Rabeprazole Sodium	Golden State Medical Supply, Inc.	ANDA	Current
55700-238	Rabeprazole Sodium	Rabeprazole Sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-467	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	DIRECT RX	ANDA	Current
61919-467	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	DIRECT RX	ANDA	Current
62175-302	Rabeprazole Sodium	Rabeprazole Sodium	Lannett Company, Inc.	ANDA	Current
62175-302	Rabeprazole Sodium	Rabeprazole Sodium	Lannett Company, Inc.	ANDA	Current
62175-302	Rabeprazole Sodium	Rabeprazole Sodium	Lannett Company, Inc..	ANDA	Current
62175-302	Rabeprazole Sodium	Rabeprazole Sodium	Lannett Company, Inc.	ANDA	Current
62175-302	Rabeprazole Sodium	Rabeprazole Sodium	Lannett Company, Inc.	ANDA	Current
63187-259	Rabeprazole Sodium	Rabeprazole Sodium	Proficient Rx LP	ANDA	Current
63187-259	Rabeprazole Sodium	Rabeprazole Sodium	Proficient Rx LP	ANDA	Current
71335-0244	Rabeprazole Sodium	Rabeprazole Sodium	Bryant Ranch Prepack	ANDA	Current
71335-0244	Rabeprazole Sodium	Rabeprazole Sodium	Bryant Ranch Prepack	ANDA	Current
71335-0244	Rabeprazole Sodium	Rabeprazole Sodium	Bryant Ranch Prepack	ANDA	Current
71335-0244	Rabeprazole Sodium	Rabeprazole Sodium	Bryant Ranch Prepack	ANDA	Current
71335-0244	Rabeprazole Sodium	Rabeprazole Sodium	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18539	ORIG	2013-11-19
9285	ORIG	2013-11-12