LOSARTAN POTASSIUM

Product NDC: 61919-030
Requested package NDC: 61919-030-30
11-digit product format: 619190030
Labeler code: 61919
Product ID: 61919-030_9c98c94b-c649-294b-e053-2a95a90ac51a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: losartan potassium tablet
Dosage form: TABLET
Route: ORAL
Labeler: Direct RX
Application: ANDA090467
Marketing category: ANDA
Marketing start: 2015-01-01
Marketing end: 0000-00-00
Substance: LOSARTAN POTASSIUM
Active strength: 50 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	61919-030	61919-030-30	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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	Approval date
A090467-001	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06
A090467-002	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06
A090467-003	LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090467-002	LOSARTAN POTASSIUM	50MG	TABLET / ORAL	2010-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090467-003	LOSARTAN POTASSIUM	100MG	TABLET / ORAL	2010-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090467-001	LOSARTAN POTASSIUM	25MG	TABLET / ORAL	2010-10-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090467-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090467-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090467-003	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A090467-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090467-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090467-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090467-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090467-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090467-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090467-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090467-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090467-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090467-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090467-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090467-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090467-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090467-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090467-003	AB	1	`ea99ee380514…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-030-30	2023-01-30	C162847	48780-1	f386c649-ea58-0266-e053-dadaa90a7c1a	LOSARTAN POTASSIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-030-30	LOSARTAN POTASSIUM	30 in 1 BOTTLE	TABLET	30	7
61919-030-90	LOSARTAN POTASSIUM	90 in 1 BOTTLE	TABLET	90	7
61919-030-90	LOSARTAN POTASSIUM	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-030-30	EA - Each	61919-030	1de7135b-dfcc-427f-8083-bccc75403f4f	1	2016-02-04
61919-030-90	EA - Each	61919-030	21ee7402-b2ac-448c-9f9e-335832c6e8e6	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOSARTAN POTASSIUM	ACTIVE INGREDIENT	3ST302B24A	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	3
LOSARTAN	ACTIVE MOIETY	JMS50MPO89	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	3
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	3
LOSARTAN POTASSIUM	ACTIVE INGREDIENT	3ST302B24A	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	1
LOSARTAN	ACTIVE MOIETY	JMS50MPO89	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-030	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	7	Legacy NDC, 2 package rows	20200130_25c32a8b-0389-2ed6-e054-00144ff8d46c.zip
61919-030	LOSARTAN POTASSIUM (LOSARTAN POTASSIUM TABLET) TABLET [DIRECT RX]	1	Legacy NDC, 1 package rows	20150630_c80b699a-5354-4f68-942f-6e92729eb8d8.zip

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
979492	losartan potassium 50 MG Oral Tablet	PSN	25c32a8b-0389-2ed6-e054-00144ff8d46c	7
979492	losartan potassium 50 MG Oral Tablet	SCD	25c32a8b-0389-2ed6-e054-00144ff8d46c	7
979492	Losartan K+ 50 MG Oral Tablet	SY	25c32a8b-0389-2ed6-e054-00144ff8d46c	7
979492	Losartan Pot 50 MG Oral Tablet	SY	25c32a8b-0389-2ed6-e054-00144ff8d46c	7
979492	losartan potassium 50 MG Oral Tablet	PSN	c80b699a-5354-4f68-942f-6e92729eb8d8	1
979492	losartan potassium 50 MG Oral Tablet	SCD	c80b699a-5354-4f68-942f-6e92729eb8d8	1
979492	Losartan K+ 50 MG Oral Tablet	SY	c80b699a-5354-4f68-942f-6e92729eb8d8	1
979492	Losartan Pot 50 MG Oral Tablet	SY	c80b699a-5354-4f68-942f-6e92729eb8d8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-030-30	61919003030	30 BOTTLE in 1 BOTTLE (61919-030-30) > 90 TABLET in 1 BOTTLE (61919-030-90)	30 bottle	2015-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LOSARTAN POTASSIUM	Direct RX	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	7
LOSARTAN POTASSIUM	Direct RX	2015-06-29	HUMAN PRESCRIPTION DRUG LABEL	1