Amiloride Hydrochloride

Product NDC: 63629-2114
11-digit product format: 636292114
Labeler code: 63629
Product ID: 63629-2114_84adc61b-3ed3-452d-a1b8-d062869b263d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amiloride Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA070346
Marketing category: ANDA
Marketing start: 1986-01-22
Substance: AMILORIDE HYDROCHLORIDE ANHYDROUS
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63629-2114		D	Discontinued by firm		2026-08-07
excluded package	package	63629-2114	63629-2114-1	D	Discontinued by firm		2026-08-07

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
A070346-001	AMILORIDE HYDROCHLORIDE	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070346-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070346-001	AMILORIDE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1986-01-22	`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	A070346-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070346-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070346-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070346-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070346-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070346-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070346-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070346-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070346-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070346-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070346-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070346-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070346-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070346-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070346-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070346-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070346-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070346-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070346-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070346-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070346-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070346-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070346-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070346-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070346-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070346-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070346-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070346-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070346-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070346-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070346-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070346-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070346-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070346-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070346-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070346-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070346-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070346-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070346-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070346-001	AB	1	`cb3db0bc1861…`

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
63629-2114-1	Amiloride Hydrochloride	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
63629-2114-1	EA - Each	63629-2114	3d35f8ab-1fc1-4476-9caf-8833c9dde5ed	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2114	AMILORIDE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 1 package rows	20231129_18d551a9-ffc7-4b14-adbd-92d84aa8e966.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amiloride Hydrochloride	AMILORIDE HYDROCHLORIDE	Endo USA, Inc.	e0cc2d44-436a-47e8-a890-589882fff4c4	2024-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070346 application number: ANDA070346
Amiloride Hydrochloride	AMILORIDE HYDROCHLORIDE	Bryant Ranch Prepack	18d551a9-ffc7-4b14-adbd-92d84aa8e966	2023-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070346 application number: ANDA070346 ndc (product): 63629-2114

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7M458Q65S3	AMILORIDE HYDROCHLORIDE ANHYDROUS	2016-88-8	AMILORIDE HYDROCHLORIDE ANHYDROUS
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	18d551a9-ffc7-4b14-adbd-92d84aa8e966	103
977880	amiloride hydrochloride 5 MG Oral Tablet	SCD	18d551a9-ffc7-4b14-adbd-92d84aa8e966	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2114-1	63629211401	1000 TABLET in 1 BOTTLE (63629-2114-1)	1000 tablet	1986-05-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amiloride Hydrochloride Tablets	Bryant Ranch Prepack	2023-11-28	HUMAN PRESCRIPTION DRUG LABEL	103