Losartan potassium Tablets, 100 mg

Product NDC: 63629-2428
11-digit product format: 636292428
Labeler code: 63629
Product ID: 63629-2428_cc3b2478-5ab1-4ee0-a162-a05b3c4f6b09
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: losartan potassium
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA201170
Marketing category: ANDA
Marketing start: 2012-09-18
Substance: LOSARTAN POTASSIUM
Active strength: 100 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A201170-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18
A201170-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18
A201170-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A201170-001	AB
A201170-002	AB
A201170-003	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 4 · 123 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	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2012-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2012-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201170-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2012-09-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A201170-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201170-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201170-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201170-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201170-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201170-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201170-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201170-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201170-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201170-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201170-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201170-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201170-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201170-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201170-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201170-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201170-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201170-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201170-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201170-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Losartan potassium Tablets, 100 mg
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOSARTAN POTASSIUM	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3ST302B24A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
979480	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
04c4ba11-a9bd-4fed-bf14-14214f33f9c2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0d341e63-aee5-498b-bf9a-b53a43963acf	Product name	1	20260105
de29c5c0-90ba-29da-d7ab-0500274708be	Product name	6	20241009
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-2428-1	Losartan potassium Tablets, 100 mg	1000 in 1 BOTTLE	TABLET	1000		103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2428-1	EA - Each	63629-2428	6024cd36-909a-4177-9707-73e88b276d87	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2428	LOSARTAN POTASSIUM TABLETS, 100 MG (LOSARTAN POTASSIUM) TABLET [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 1 package rows	20240112_04c4ba11-a9bd-4fed-bf14-14214f33f9c2.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan potassium Tablets, 25 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	7b8f5329-4fdb-4e1d-98b1-de1ca1b171c5	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 100 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	726002cf-2d95-4dac-b1f6-e7f92bb13496	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 50 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	d67926b0-c22b-4803-b55d-c98a81389449	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 50 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	3d7ddcac-508d-459c-96c8-c62f9c0b5193	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 50 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	eea03814-3fb5-4f85-8a4d-18e73057d880	2025-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 100 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	04c4ba11-a9bd-4fed-bf14-14214f33f9c2	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170 ndc (product): 63629-2428
Losartan potassium Tablets, 25 mg	LOSARTAN POTASSIUM	Bryant Ranch Prepack	ee58207e-3913-4262-87ec-930bb4ecf07b	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 100 mg	LOSARTAN POTASSIUM	Coupler LLC	2d1b03bb-2355-baac-e063-6294a90a9b40	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170
Losartan potassium Tablets, 25 mg	LOSARTAN POTASSIUM	Jubilant Cadista Pharmaceuticals Inc.	1bf520a2-a50e-a6ae-0fdf-9be4e69729c0	2024-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201170 application number: ANDA201170

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3ST302B24A	LOSARTAN POTASSIUM	124750-99-8	LOSARTAN POTASSIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
979480	losartan potassium 100 MG Oral Tablet	PSN	04c4ba11-a9bd-4fed-bf14-14214f33f9c2	103
979480	losartan potassium 100 MG Oral Tablet	SCD	04c4ba11-a9bd-4fed-bf14-14214f33f9c2	103
979480	Losartan K+ 100 MG Oral Tablet	SY	04c4ba11-a9bd-4fed-bf14-14214f33f9c2	103
979480	Losartan Pot 100 MG Oral Tablet	SY	04c4ba11-a9bd-4fed-bf14-14214f33f9c2	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2428-1	63629242801	1000 TABLET in 1 BOTTLE (63629-2428-1)	1000 tablet	2021-02-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Losartan potassium Tablets, 100 mg	Bryant Ranch Prepack	2025-09-04	HUMAN PRESCRIPTION DRUG LABEL	103