Rabeprazole Sodium

Product NDC: 85509-1443
11-digit product format: 855091443
Labeler code: 85509
Product ID: 85509-1443_3a675606-7bc5-5da5-e063-6294a90ac109
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rabeprazole Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: PHOENIX RX LLC
Application: ANDA208644
Marketing category: ANDA
Marketing start: 2018-04-27
Substance: RABEPRAZOLE SODIUM
Active strength: 20 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC], Proton Pump 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 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
A208644-001	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB		2018-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208644-001	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	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`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	A208644-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208644-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208644-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208644-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208644-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208644-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208644-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208644-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208644-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208644-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208644-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208644-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208644-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208644-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208644-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208644-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208644-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208644-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208644-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208644-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208644-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208644-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208644-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208644-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208644-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208644-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208644-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208644-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208644-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208644-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208644-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208644-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208644-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208644-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208644-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208644-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208644-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208644-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208644-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208644-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RABEPRAZOLE SODIUM	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3L36P16U4R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
854868	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
3a674849-b2f6-5f43-e063-6294a90a9e20	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4	Product name	4	20180626
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
9a0b93b8-7081-4ac2-867c-2955b2d759fd	Product name	2	20170909
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
85509-1443-3	Rabeprazole Sodium	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	1
85509-1443-6	Rabeprazole Sodium	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	1
85509-1443-9	Rabeprazole Sodium	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
85509-1443-3	EA - Each	85509-1443	2bca9c5c-33d0-42b3-8568-13f4edb0869b	1	2025-09-12
85509-1443-6	EA - Each	85509-1443	afea94cf-54cd-4a6c-a065-a6bb41e1c6a5	1	2025-09-12
85509-1443-9	EA - Each	85509-1443	00852f83-2308-4f4a-89bc-b4518b01095a	1	2025-09-12

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rabeprazole Sodium	RABEPRAZOLE SODIUM	REMEDYREPACK INC.	63e0b7ca-6b2d-42a9-b9d4-4523b8a20425	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	St. Mary's Medical Park Pharmacy	9237eaa4-8eec-fb2a-e053-2995a90ab6c0	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Proficient Rx LP	68b7a793-f22b-4609-a640-94fdec703d93	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium DR	RABEPRAZOLE SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	bdad0b58-495e-2352-e053-2a95a90a3198	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium DR	RABEPRAZOLE SODIUM	Advanced Rx of Tennessee, LLC	b354053c-cb83-79c6-e053-2a95a90afdbe	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Asclemed USA, Inc.	3b6a25c2-fb61-4c86-9988-c6ffac7939c4	2026-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Preferred Pharmaceuticals, Inc.	ac9266ed-a9b2-4e77-8607-393b5dcdd2b6	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	PHOENIX RX LLC	3a674849-b2f6-5f43-e063-6294a90a9e20	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644 ndc (product): 85509-1443
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	DIRECT RX	b1b7def0-834f-37f5-e053-2a95a90ade1f	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	9ea2552c-873c-4ab2-84b0-dd54e84e4eee	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	8d8c1a72-b4c4-4699-b9c3-3a39a9df44f2	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Ascend Laboratories, LLC	45092108-7c4a-48f9-8222-ca8612e82189	2023-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	A-S Medication Solutions	4ded337a-31b8-47c3-b5ab-33a785afb7d8	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3L36P16U4R	RABEPRAZOLE SODIUM	117976-90-6	RABEPRAZOLE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854868	RABEprazole sodium 20 MG Delayed Release Oral Tablet	PSN	3a674849-b2f6-5f43-e063-6294a90a9e20	1
854868	rabeprazole sodium 20 MG Delayed Release Oral Tablet	SCD	3a674849-b2f6-5f43-e063-6294a90a9e20	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
85509-1443-3	85509144303	30 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1443-3)	2025-07-17	No	No	Current
85509-1443-6	85509144306	60 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1443-6)	2025-07-17	No	No	Current
85509-1443-9	85509144309	90 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1443-9)	2025-07-17	No	No	Current