amiloride hydrochloride

Product NDC: 0574-0292
11-digit product format: 005740292
Labeler code: 0574
Product ID: 0574-0292_416c3aaf-7390-40cf-995a-31258156b4f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amiloride hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Padagis US LLC
Application: NDA018200
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2009-04-06
Substance: AMILORIDE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018200-001	MIDAMOR	AMILORIDE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018200-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018200-001	MIDAMOR	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018200-001	MIDAMOR	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018200-001	MIDAMOR	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AB	RLD, Approved before 1982	`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	N018200-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018200-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018200-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018200-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018200-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018200-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018200-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018200-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018200-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018200-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018200-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018200-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018200-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018200-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018200-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018200-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018200-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018200-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018200-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018200-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018200-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018200-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018200-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018200-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018200-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018200-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018200-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018200-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018200-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018200-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018200-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018200-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018200-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018200-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018200-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018200-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018200-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018200-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018200-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018200-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: amiloride hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMILORIDE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FZJ37245UC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
977880	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
2b70cf0c-45be-428f-b396-5001ed4e30fc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7954898a-d540-405e-aa1d-3553358552e5	Product name	1	20150812

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0574-0292-01	amiloride hydrochloride	100 in 1 BOTTLE	TABLET	100		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0574-0292-01	EA - Each	0574-0292	8d674f1a-d0ba-4da6-87bb-8f9379876f56	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMILORIDE HYDROCHLORIDE	ACTIVE INGREDIENT	FZJ37245UC	AMILORIDE HYDROCLORIDE TABLET [PADDOCK LABORATORIES, LLC]	2
AMILORIDE	ACTIVE MOIETY	7DZO8EB0Z3	AMILORIDE HYDROCLORIDE TABLET [PADDOCK LABORATORIES, LLC]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	AMILORIDE HYDROCLORIDE TABLET [PADDOCK LABORATORIES, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMILORIDE HYDROCLORIDE TABLET [PADDOCK LABORATORIES, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMILORIDE HYDROCLORIDE TABLET [PADDOCK LABORATORIES, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMILORIDE HYDROCLORIDE TABLET [PADDOCK LABORATORIES, LLC]	2
AMILORIDE HYDROCHLORIDE	ACTIVE INGREDIENT	FZJ37245UC	AMILORIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
AMILORIDE	ACTIVE MOIETY	7DZO8EB0Z3	AMILORIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	AMILORIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMILORIDE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0574-0292	AMILORIDE HYDROCHLORIDE TABLET [PADAGIS US LLC]	7	Current NDC, Legacy NDC, 1 package rows	20241123_2b70cf0c-45be-428f-b396-5001ed4e30fc.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
amiloride hydrochloride	AMILORIDE HYDROCHLORIDE	Padagis US LLC	2b70cf0c-45be-428f-b396-5001ed4e30fc	2023-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018200 application number: NDA018200 ndc (product): 0574-0292

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FZJ37245UC	AMILORIDE HYDROCHLORIDE	17440-83-4	AMILORIDE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
977880	aMILoride HCl 5 MG Oral Tablet	PSN	2b70cf0c-45be-428f-b396-5001ed4e30fc	7
977880	amiloride hydrochloride 5 MG Oral Tablet	SCD	2b70cf0c-45be-428f-b396-5001ed4e30fc	7
977880	aMILoride HCl 5 MG Oral Tablet	PSN	1cf090a2-b6c0-42cd-857e-60a9cd85fe19	1
977880	amiloride hydrochloride 5 MG Oral Tablet	SCD	1cf090a2-b6c0-42cd-857e-60a9cd85fe19	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0574-0292-01	00574029201	100 TABLET in 1 BOTTLE (0574-0292-01)	100 tablet	2009-04-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amiloride HCl Tablets, USP	Padagis US LLC	2023-05-05	HUMAN PRESCRIPTION DRUG LABEL	7
Amiloride HCl Tablets, USP	Physicians Total Care, Inc.	2009-06-30	HUMAN PRESCRIPTION DRUG LABEL	1