Application 091292

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	SUSPENSION;ORAL	1MG/7.5ML	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
A091292-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL			2011-05-20

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL	2011-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL	2011-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091292-001	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SUSPENSION / ORAL	2011-05-20	`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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good neighbor pharmacy loperamide hydrochloride	LOPERAMIDE HCL	Amerisource Bergen	53f66b4a-b97b-4995-b2cf-e33afe996af1	2025-04-11	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292 ndc (product): 46122-544
Anti Diarrheal	LOPERAMIDE HCL	Walgreen Company	f70d0568-27c0-4c63-8d68-82e31b87174f	2025-04-11	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292 ndc (product): 0363-2022
basic care loperamide hydrochloride	LOPERAMIDE HCL	Amazon.com Services LLC	d6b8015c-f8fe-45cb-891f-566fb319b46b	2025-04-03	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
topcare loperamide hydrochloride	LOPERAMIDE HCL	Topco Associates LLC	1cd497b4-d97e-447a-9251-710d2fddbf23	2025-04-01	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292 ndc (product): 36800-583
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Safeway	9d0c565f-64a2-4300-b1e2-5dee9546ea14	2024-10-22	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292
loperamide hydrochloride	LOPERAMIDE HCL	Rite Aid Corporation	56334ed4-8cb0-4f5c-9051-6836f0e21337	2024-06-28	Warnings	Exact identifier application applno (ANDA): 091292 application number: ANDA091292 ndc (product): 11822-5519

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 119 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0645	good sense loperamide hydrochloride	loperamide HCl	L. Perrigo Company	ANDA	Current
0113-1645	Good Sense antidiarrheal	loperamide HCl	L. Perrigo Company	ANDA	Current
0113-1645	Good Sense antidiarrheal	loperamide HCl	L. Perrigo Company	ANDA	Current
0363-0645	loperamide hydrochloride	loperamide HCl	Walgreen Company	ANDA	Current
0363-1645	loperamide hydrochloride	loperamide HCl	Walgreen Company	ANDA	Current
0363-1645	loperamide hydrochloride	loperamide HCl	Walgreen Company	ANDA	Current
0363-1645	loperamide hydrochloride	loperamide HCl	Walgreen Company	ANDA	Current
0363-2022	Anti Diarrheal	loperamide HCl	Walgreen Company	ANDA	Current
0904-6256	loperamide hydrochloride	loperamide HCl	Major Pharmaceuticals	ANDA	Current
0904-6836	loperamide hydrochloride	loperamide HCl	Major Pharmaceuticals	ANDA	Current
0904-6836	loperamide hydrochloride	loperamide HCl	Major Pharmaceuticals	ANDA	Current
0904-6836	loperamide hydrochloride	loperamide HCl	Major Pharmaceuticals	ANDA	Current
10202-645	7 select anti diarrheal	loperamide HCl	7-Eleven	ANDA	Current
10202-645	7 select anti diarrheal	loperamide HCl	7-Eleven	ANDA	Current
11673-900	Up and Up anti diarrheal	loperamide HCl	Target Corporation	ANDA	Current
11673-900	Up and Up anti diarrheal	loperamide HCl	Target Corporation	ANDA	Current
11822-1645	loperamide hydrochloride	loperamide HCl	Rite Aid Corporation	ANDA	Current
11822-5519	loperamide hydrochloride	loperamide HCl	Rite Aid Corporation	ANDA	Current
11822-5519	loperamide hydrochloride	loperamide HCl	Rite Aid Corporation	ANDA	Current
11822-5519	loperamide hydrochloride	loperamide HCl	Rite Aid Corporation	ANDA	Current
17856-0111	good neighbor pharmacy Loperamide hydrochloride	loperamide HCl	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0111	good neighbor pharmacy Loperamide hydrochloride	loperamide HCl	ATLANTIC BIOLOGICALS CORP	ANDA	Current
17856-0111	good neighbor pharmacy Loperamide hydrochloride	loperamide HCl	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0545	good neighbor pharmacy loperamide hydrochloride	loperamide HCl	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0545	good neighbor pharmacy loperamide hydrochloride	loperamide HCl	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-6836	loperamide hydrochloride	loperamide HCl	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-6836	loperamide hydrochloride	loperamide HCl	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
21130-131	signature care anti diarrheal	loperamide HCl	Safeway	ANDA	Current
21130-440	signature care anti diarrheal	loperamide HCl	Safeway	ANDA	Current
21130-440	signature care anti diarrheal	loperamide HCl	Safeway	ANDA	Current
30142-514	anti diarrheal	loperamide HCl	Kroger Company	ANDA	Current
30142-514	anti diarrheal	loperamide HCl	Kroger Company	ANDA	Current
30142-645	Loperamide Hydrochloride	loperamide HCl	Kroger Company	ANDA	Current
36800-583	topcare loperamide hydrochloride	loperamide HCl	Topco Associates LLC	ANDA	Current
36800-583	topcare loperamide hydrochloride	loperamide HCl	Topco Associates LLC	ANDA	Current
36800-583	topcare loperamide hydrochloride	loperamide HCl	Topco Associates LLC	ANDA	Current
36800-583	topcare loperamide hydrochloride	loperamide HCl	Topco Associates LLC	ANDA	Current
36800-645	topcare loperamide hydrochloride	loperamide HCl	Topco Associates LLC	ANDA	Current
37205-584	Leader Loperamide Hydrochloride	loperamide HCl	Cardinal Health	ANDA	Current
37808-449	anti diarrheal	loperamide HCl	H E B	ANDA	Current
37808-449	anti diarrheal	loperamide HCl	H E B	ANDA	Current
37808-645	Loperamide Hydrochloride	loperamide HCl	H E B	ANDA	Current
41163-210	equaline loperamide hydrochloride	loperamide HCl	Supervalu Inc	ANDA	Current
41163-210	equaline loperamide hydrochloride	loperamide HCl	Supervalu Inc	ANDA	Current
41163-645	Equaline loperamide hydrochloride	loperamide HCl	Supervalu Inc	ANDA	Current
41250-645	loperamide hydrochloride	loperamide HCl	Meijer Distribution Inc	ANDA	Current
41250-813	loperamide hydrochloride	loperamide HCl	Meijer Distribution Inc	ANDA	Current
41250-813	loperamide hydrochloride	loperamide HCl	Meijer Distribution Inc	ANDA	Current
41520-645	CareOne loperamide hydrochloride	loperamide HCl	American Sales Company	ANDA	Current
41520-767	CareOne Diarrhea Control	loperamide HCl	American Sales Company	ANDA	Current
41520-767	CareOne Diarrhea Control	loperamide HCl	American Sales Company	ANDA	Current
41520-841	CareOne Diarrhea Control	Loperamide Hydrochloride	American Sales Company	ANDA	Current
41520-841	CareOne Diarrhea Control	Loperamide Hydrochloride	American Sales Company	ANDA	Current
46122-111	good neighbor pharmacy Loperamide hydrochloride	loperamide HCl	Amerisource Bergen	ANDA	Current
46122-241	Good Neighbor Pharmacy Loperamide Hydrochloride	Loperamide Hydrochloride	Amerisource Bergen	ANDA	Current
46122-241	Good Neighbor Pharmacy Loperamide Hydrochloride	Loperamide Hydrochloride	Amerisource Bergen	ANDA	Current
46122-544	good neighbor pharmacy loperamide hydrochloride	loperamide HCl	Amerisource Bergen	ANDA	Current
46122-544	good neighbor pharmacy loperamide hydrochloride	loperamide HCl	Amerisource Bergen	ANDA	Current
46122-546	Good Neighbor Pharmacy Loperamide Hydrochloride	Loperamide HCl	Amerisource Bergen	ANDA	Current
49035-451	Equate Loperamide Hydrochloride	loperamide HCl	Wal-Mart Stores Inc	ANDA	Current
49035-451	Equate Loperamide Hydrochloride	loperamide HCl	Wal-Mart Stores Inc	ANDA	Current
49035-451	Equate Loperamide Hydrochloride	loperamide HCl	Wal-Mart Stores Inc	ANDA	Current
49035-451	Equate Loperamide Hydrochloride	loperamide HCl	Wal-Mart Stores Inc	ANDA	Current
49035-645	Equate Loperamide Hydrochloride	loperamide HCl	Wal-Mart Stores Inc	ANDA	Current
49035-645	Equate Loperamide Hydrochloride	loperamide HCl	Wal-Mart Stores Inc	ANDA	Current
49035-695	equate diarrhea control	Loperamide HCl	Wal-Mart Stores Inc	ANDA	Current
49348-999	sunmark loperamide hydrochloride	loperamide HCl	McKesson	ANDA	Current
49348-999	sunmark loperamide hydrochloride	loperamide HCl	Strategic Sourcing Services LLC	ANDA	Current
49738-383	Smart Sense anti diarrheal	loperamide HCl	Kmart Corporation	ANDA	Current
49738-645	smart sense loperamide hydrochloride	loperamide HCl	Kmart Corporation	ANDA	Current
49781-061	Leader Loperamide Hydrochloride	loperamide HCl	Cardinal Health	ANDA	Current
49781-089	leader loperamide	Loperamide Hydrochloride	Cardinal Health	ANDA	Current
50090-4450	sunmark anti diarrheal	loperamide HCl	A-S Medication Solutions	ANDA	Current
50090-4450	sunmark anti diarrheal	loperamide HCl	A-S Medication Solutions	ANDA	Current
55316-645	Healthy Accents Anti Diarrheal	loperamide HCl	DZA Brands LLC	ANDA	Current
55910-645	dg health loperamide hydrochloride	loperamide HCl	Dolgencorp Inc	ANDA	Current
55910-867	DG Health Anti Diarrheal	loperamide HCl	Dolgencorp Inc	ANDA	Current
59779-645	loperamide hydrochloride	loperamide HCl	CVS Pharmacy	ANDA	Current
59779-758	Loperamide Hydrochloride	Loperamide Hydrochloride	CVS Pharmacy	ANDA	Current
59779-758	Loperamide Hydrochloride	Loperamide Hydrochloride	CVS Pharmacy	ANDA	Current