Application 070346

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMILORIDE HYDROCHLORIDE	AMILORIDE HYDROCHLORIDE	TABLET;ORAL	5MG	No	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
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…`

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 ndc (product): 49884-117
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-117	Amiloride Hydrochloride	Amiloride Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-117	Amiloride Hydrochloride	Amiloride Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-117	Amiloride Hydrochloride	Amiloride Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
60429-275	Amiloride Hydrochloride	Amiloride Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-275	Amiloride Hydrochloride	Amiloride Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-275	Amiloride Hydrochloride	Amiloride Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-275	Amiloride Hydrochloride	Amiloride Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
63629-2114	Amiloride Hydrochloride	Amiloride Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2114	Amiloride Hydrochloride	Amiloride Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2114	Amiloride Hydrochloride	Amiloride Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68151-0162	Amiloride Hydrochloride	Amiloride Hydrochloride	Carilion Materials Management	ANDA	Current