Loperamide Hydrochloride

Product NDC: 68788-8393
11-digit product format: 687888393
Labeler code: 68788
Product ID: 68788-8393_4e0998b5-f4d3-4f1d-9244-07f3c78308c6
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA206548
Marketing category: ANDA
Marketing start: 2023-03-01
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A206548-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL			2015-12-15

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Loperamide Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOPERAMIDE HYDROCHLORIDE	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
77TI35393C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
978010	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8393-2	Loperamide Hydrochloride	6 in 1 BLISTER PACK	TABLET	6		4
68788-8393-2	Loperamide Hydrochloride	4 in 1 CARTON	TABLET	4		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8393-2	EA - Each	68788-8393	75852d5f-2064-4d8e-8cdc-08fedb3dc98a	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8393	LOPERAMIDE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, 2 package rows	20240627_5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	YYBA CORP	568064c9-139d-7233-e063-6294a90a10d4	2026-08-10	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aurobindo Pharma Limited	8e4004be-bf79-4631-9e38-c4e7b6726313	2026-06-03	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548
AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Proficient Rx LP	5e1358fc-76de-486a-80dd-7f41e037d9a0	2026-06-01	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf	2026-05-28	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548 ndc (product): 68788-8393
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aurohealth LLC	f3ea8779-252e-4038-ae41-500e15c54825	2025-01-22	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548
AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Amazon.com Services LLC	10edd7bc-fc35-abe3-e063-6394a90aeb3f	2024-05-15	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Amerisource Bergen	6c15f077-9f90-4262-9c17-a1ac70e45f57	2024-03-29	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aurohealth LLC	93ebbb23-a9f0-4519-9793-c9056be39f23	2022-03-22	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548

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	5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf	5
978010	loperamide hydrochloride 2 MG Oral Tablet	SCD	5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8393-2	68788839302	4 BLISTER PACK in 1 CARTON (68788-8393-2) / 6 TABLET in 1 BLISTER PACK	4 blister pack	2023-03-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loperamide Hydrochloride - Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	2026-05-28	HUMAN OTC DRUG LABEL	5