Application 072741

Type: ANDA
Sponsor: MYLAN

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A072741-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072741-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A072741-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072741-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072741-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072741-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072741-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072741-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072741-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072741-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072741-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072741-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072741-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072741-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072741-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072741-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072741-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072741-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072741-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072741-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072741-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072741-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072741-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072741-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072741-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072741-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072741-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072741-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072741-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072741-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072741-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072741-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072741-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072741-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072741-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072741-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072741-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072741-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072741-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072741-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072741-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072741-001	AB	1	`e64feba35796…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Cardinal Health 107, LLC	be99224e-dd49-4628-a5bf-ed8469ffd4a4	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741 ndc (product): 55154-5585
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Cardinal Health 107, LLC	74b9893a-18c3-4117-85c2-edab8e7b3b3b	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Safecor Health LLC	8b0ac05b-90c1-476b-b001-5801dd21701d	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Mylan Institutional Inc.	ad71d4ab-d293-47a2-8f3f-2c9f42d76e40	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741 ndc (product): 51079-690
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c5322892-cb14-4a25-9b42-e62e491bc101	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	f092b8a5-80b0-40ba-af45-2ac9edaa7704	2023-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741 ndc (product): 71335-1921
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	72a7ae47-cdf3-4949-b9f8-f29b153f787f	2022-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741 ndc (product): 0378-2100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-2100	Loperamide Hydrochloride	loperamide hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2100	Loperamide Hydrochloride	loperamide hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2100	Loperamide Hydrochloride	loperamide hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-0362	Loperamide Hydrochloride	loperamide hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8087	Loperamide Hydrochloride	loperamide hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43063-431	Loperamide Hydrochloride	loperamide hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-2859	Loperamide Hydrochloride	loperamide hydrochloride	A-S Medication Solutions	ANDA	Current
50436-3974	Loperamide Hydrochloride	loperamide hydrochloride	Unit Dose Services	ANDA	Current
51079-690	Loperamide Hydrochloride	loperamide hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-690	Loperamide Hydrochloride	loperamide hydrochloride	Mylan Institutional Inc.	ANDA	Current
55154-5585	Loperamide Hydrochloride	loperamide hydrochloride	Cardinal Health	ANDA	Current
55154-5585	Loperamide Hydrochloride	loperamide hydrochloride	Cardinal Health 107, LLC	ANDA	Current
55154-5585	Loperamide Hydrochloride	loperamide hydrochloride	Cardinal Health	ANDA	Current
55154-5585	Loperamide Hydrochloride	loperamide hydrochloride	Cardinal Health	ANDA	Current
67046-456	Loperamide Hydrochloride	loperamide hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
67296-0129	Loperamide Hydrochloride	loperamide hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67544-700	Loperamide Hydrochloride	loperamide hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-700	Loperamide Hydrochloride	loperamide hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
70518-0313	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0313	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0313	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0313	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0313	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0313	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0313	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0893	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0893	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0893	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0893	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0893	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0893	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0893	Loperamide Hydrochloride	loperamide hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-1921	Loperamide Hydrochloride	loperamide hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1921	Loperamide Hydrochloride	loperamide hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1921	Loperamide Hydrochloride	loperamide hydrochloride	Bryant Ranch Prepack	ANDA	Current