Application 215579

Type: ANDA
Sponsor: BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	CAPSULE;ORAL	2MG	No	No

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
A215579-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB		2021-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215579-001	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.

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	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215579-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215579-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215579-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215579-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215579-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215579-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215579-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215579-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215579-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215579-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215579-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215579-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215579-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215579-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215579-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215579-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215579-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215579-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215579-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215579-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215579-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215579-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215579-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215579-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215579-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215579-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215579-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215579-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215579-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215579-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215579-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215579-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215579-001	AB	1	`a50c72e98297…`

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
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	AvPAK	f8992723-dd9a-bcf6-e053-6294a90aa65c	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215579 application number: ANDA215579
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	df4e7076-fd25-aeb8-e053-2995a90a2aa0	2024-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215579 application number: ANDA215579 ndc (product): 68071-2700
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	691c5dd6-b85d-482b-a8c1-8c4b48b48dc9	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215579 application number: ANDA215579 ndc (product): 71335-2061
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bionpharma Inc.	6e60cb25-6af9-4f17-b740-a5e7b5bb2a09	2023-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215579 application number: ANDA215579 ndc (product): 69452-271

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68071-2700	Loperamide Hydrochloride	Loperamide Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2700	Loperamide Hydrochloride	Loperamide Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2863	Loperamide Hydrochloride	loperamide hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
69452-271	Loperamide Hydrochloride	loperamide hydrochloride	Bionpharma Inc.	ANDA	Current
69452-271	Loperamide Hydrochloride	loperamide hydrochloride	Bionpharma Inc.	ANDA	Current
70518-3400	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3400	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3400	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-2061	Loperamide Hydrochloride	loperamide hydrochloride	Bryant Ranch Prepack	ANDA	Current