Losartan Potassium

Product NDC: 29300-146
Requested package NDC: 29300-146-13
11-digit product format: 293000146
Labeler code: 29300
Product ID: 29300-146_cedb47f7-7b7e-464f-b1ed-2a3afdb074d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Losartan Potassium
Dosage form: TABLET
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA203030
Marketing category: ANDA
Marketing start: 2015-10-14
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
A203030-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2015-10-14
A203030-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2015-10-14
A203030-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2015-10-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203030-001	AB
A203030-002	AB
A203030-003	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	A203030-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2015-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203030-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2015-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203030-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2015-10-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203030-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2015-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203030-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2015-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203030-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2015-10-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203030-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2015-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203030-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2015-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203030-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2015-10-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203030-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2015-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203030-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2015-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203030-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2015-10-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203030-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2015-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203030-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2015-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203030-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2015-10-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203030-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2015-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203030-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2015-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203030-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2015-10-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203030-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2015-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203030-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2015-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203030-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2015-10-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203030-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2015-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203030-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2015-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203030-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2015-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203030-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2015-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203030-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2015-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203030-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2015-10-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203030-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2015-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203030-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2015-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203030-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2015-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203030-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2015-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203030-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2015-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203030-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2015-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203030-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2015-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203030-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2015-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203030-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2015-10-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203030-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2015-10-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203030-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	AB	2015-10-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203030-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	AB	2015-10-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203030-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	AB	2015-10-14	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A203030-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203030-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203030-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203030-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203030-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203030-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203030-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203030-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203030-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203030-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203030-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203030-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203030-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203030-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203030-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203030-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203030-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203030-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203030-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203030-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203030-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203030-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203030-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203030-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203030-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203030-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203030-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203030-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203030-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203030-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203030-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203030-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203030-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203030-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203030-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203030-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203030-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203030-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203030-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203030-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Losartan Potassium
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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
979480	Internal RxNorm lookup
979485	Internal RxNorm lookup
979492	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
92691768-b5e6-4527-98dc-d86c58f6f13e	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
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
29300-146-01	Losartan Potassium	100 in 1 BOTTLE, PLASTIC	TABLET	100	16
29300-146-10	Losartan Potassium	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	16
29300-146-13	Losartan Potassium	30 in 1 BOTTLE, PLASTIC	TABLET	30	16
29300-146-19	Losartan Potassium	90 in 1 BOTTLE, PLASTIC	TABLET	90	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-146-19	EA - Each	29300-146	f1b8a5f2-fb95-46a0-9816-072368c3da94	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-146	LOSARTAN POTASSIUM TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	14	Current NDC, Legacy NDC, 4 package rows	20221129_92691768-b5e6-4527-98dc-d86c58f6f13e.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Losartan Potassium	LOSARTAN POTASSIUM	Unichem Pharmaceuticals (USA), Inc.	92691768-b5e6-4527-98dc-d86c58f6f13e	2025-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203030 application number: ANDA203030 ndc (package): 29300-146-13 ndc (product): 29300-146 ndc11 (package): 29300014613
Losartan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	35856cd6-3fc7-2c03-e063-6294a90a2f69	2025-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203030 application number: ANDA203030
Losartan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	3585b1d3-ccb7-747e-e063-6294a90a4b77	2025-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203030 application number: ANDA203030
Losartan Potassium	LOSARTAN POTASSIUM	Bryant Ranch Prepack	3585fdcc-d22a-b0a6-e063-6294a90a9b0c	2025-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203030 application number: ANDA203030

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	92691768-b5e6-4527-98dc-d86c58f6f13e	16
979485	losartan potassium 25 MG Oral Tablet	PSN	92691768-b5e6-4527-98dc-d86c58f6f13e	16
979492	losartan potassium 50 MG Oral Tablet	PSN	92691768-b5e6-4527-98dc-d86c58f6f13e	16
979480	losartan potassium 100 MG Oral Tablet	SCD	92691768-b5e6-4527-98dc-d86c58f6f13e	16
979485	losartan potassium 25 MG Oral Tablet	SCD	92691768-b5e6-4527-98dc-d86c58f6f13e	16
979492	losartan potassium 50 MG Oral Tablet	SCD	92691768-b5e6-4527-98dc-d86c58f6f13e	16
979480	Losartan K+ 100 MG Oral Tablet	SY	92691768-b5e6-4527-98dc-d86c58f6f13e	16
979485	Losartan K+ 25 MG Oral Tablet	SY	92691768-b5e6-4527-98dc-d86c58f6f13e	16
979492	Losartan K+ 50 MG Oral Tablet	SY	92691768-b5e6-4527-98dc-d86c58f6f13e	16
979480	Losartan Pot 100 MG Oral Tablet	SY	92691768-b5e6-4527-98dc-d86c58f6f13e	16
979485	Losartan Pot 25 MG Oral Tablet	SY	92691768-b5e6-4527-98dc-d86c58f6f13e	16
979492	Losartan Pot 50 MG Oral Tablet	SY	92691768-b5e6-4527-98dc-d86c58f6f13e	16
979480	losartan potassium 100 MG Oral Tablet	PSN	3585fdcc-d22a-b0a6-e063-6294a90a9b0c	1
979480	losartan potassium 100 MG Oral Tablet	SCD	3585fdcc-d22a-b0a6-e063-6294a90a9b0c	1
979480	Losartan K+ 100 MG Oral Tablet	SY	3585fdcc-d22a-b0a6-e063-6294a90a9b0c	1
979480	Losartan Pot 100 MG Oral Tablet	SY	3585fdcc-d22a-b0a6-e063-6294a90a9b0c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-146-13	29300014613	30 TABLET in 1 BOTTLE, PLASTIC (29300-146-13)	30 tablet	2018-02-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Losartan Potassium	Unichem Pharmaceuticals (USA), Inc.	2025-09-02	HUMAN PRESCRIPTION DRUG LABEL	16
Losartan Potassium	Bryant Ranch Prepack	2025-05-19	HUMAN PRESCRIPTION DRUG LABEL	1