Loperamide Hydrochloride

Product NDC: 46122-169
11-digit product format: 461220169
Labeler code: 46122
Product ID: 46122-169_80a4c80a-d34f-48d8-8484-f605ad892a25
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Amerisource Bergen
Application: ANDA074091
Marketing category: ANDA
Marketing start: 1993-02-01
Marketing end: 0000-00-00
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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	46122-169		I	Inactivated by FDA		2026-08-03
excluded package	package	46122-169	46122-169-08	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46122-169-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46122-169-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46122-169-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46122-169-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46122-169-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46122-169-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46122-169-08	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46122-169-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46122-169-08	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	46122-169-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	46122-169-08	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	46122-169-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	46122-169-08	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	46122-169-08	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	46122-169-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	46122-169-08	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	46122-169-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	46122-169-08	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	46122-169-08	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	46122-169-08	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	46122-169-08	`9bebd1f3094a…`	`5416666fcb17…`

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
A074091-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL			1992-12-10

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	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074091-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	1992-12-10	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
10f838ef-a72b-645d-80f8-e2255205c3b1	Product name	6	20240805

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
46122-169-08	2020-01-31	C162847	48780-1	9d75b9d0-eb63-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46122-169-08	Loperamide Hydrochloride	72 in 1 BOTTLE	TABLET	72		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46122-169-08	EA - Each	46122-169	31b2cb1b-1d82-47bb-8aad-f2275301df7f	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]	1
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]	1
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]	1
TRISTEARIN	INACTIVE INGREDIENT	P6OCJ2551R	LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46122-169	LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN]	1	Legacy NDC, 1 package rows	20121121_cb8de80f-8a28-4eb1-a431-01ff8f32d756.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Sportpharm LLC	eb93a17e-7daf-4a9e-94a1-442039a383bd	2026-06-26	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
MEDIQUE Diamode	LOPERAMIDE HYDROCHLORIDE	Sportpharm LLC	ac674e5a-94df-4a35-9854-4e66cc17e509	2026-04-24	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Private Label Distributor	LOPERAMIDE HCL 2 MG	Unifirst First Aid Corporation	069e7979-a223-4819-b6cf-ea2731bf156b	2025-12-01	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
MEDIQUE Diamode	LOPERAMIDE HYDROCHLORIDE	Proficient Rx LP	9cf77219-c98d-487a-a5d3-61ceda6c65f5	2025-10-01	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Medline Industries, LP	03d68bcf-6413-4fe3-8263-39cc315452d2	2024-12-29	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Anti-Diarrheal	LOPERAMIDE HCI	Lil' Drug Store Products, Inc.	eec84fa1-262f-6e77-e053-2995a90a325b	2024-12-29	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Anti-Diarrheal, Circle K	LOPERAMIDE HCL TABLET	Lil' Drug Store Products, Inc.	d3aaad65-f4cd-5eb0-e053-2995a90ade84	2024-12-29	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Anti-Diarrheal, Caseys 4good	LOPERAMIDE HCL	Lil' Drug Store Products, Inc.	043b0ab4-8fba-37d1-e063-6394a90a4cd4	2024-12-29	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Lil Drug Store Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	fc23b13e-3005-4f23-aec2-b02a0e48ea11	2024-11-27	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Chain Drug Consortium, LLC	b070896b-1e22-41d4-a66d-8d3be1699217	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Zee Medical Inc	07e1f89c-5bf6-4539-848a-4435e7deb0d2	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Ohm Laboratories Inc.	c26c15a1-3a8a-4562-8c5e-ebbc8b81e0c6	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Discount Drug Mart	6bc9771d-09f8-47ce-bbbd-8dd9aae97693	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Marc Glassman, Inc.	01efdce1-25ce-45ff-aeb6-f6fba00e59aa	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Valu Merchandisers Company	33335063-49a9-4e08-9d77-4cd80e94f021	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Fred's Inc.	a3bf91ae-22f3-4402-b73c-de026f2d0475	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Chain Drug Marketing Association Inc.	237b845b-0f02-410d-9750-c95123e6142d	2024-01-11	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Handy Solutions Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	76e32e66-4af5-47a5-83ff-cbba206975d6	2023-03-15	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Proficient Rx LP	82e65393-25b7-4114-9c71-5840ee8bad84	2022-05-02	Warnings	Exact identifier application applno (ANDA): 074091 application number: ANDA074091

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
77TI35393C	LOPERAMIDE HYDROCHLORIDE	34552-83-5	LOPERAMIDE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
978010	loperamide HCl 2 MG Oral Tablet	PSN	cb8de80f-8a28-4eb1-a431-01ff8f32d756	1
978010	loperamide hydrochloride 2 MG Oral Tablet	SCD	cb8de80f-8a28-4eb1-a431-01ff8f32d756	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
46122-169-08	46122016908	72 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Amerisource Bergen \| Ranbaxy Pharmaceuticals Inc. \| Ohm Laboratories Inc.	2012-10-23	HUMAN OTC DRUG LABEL	1