anti diarrheal

Product NDC: 59779-960
11-digit product format: 597790960
Labeler code: 59779
Product ID: 59779-960_07f3d9cb-4c44-40fd-b85f-c0ed6b02471f
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: CVS Pharmacy
Application: ANDA075232
Marketing category: ANDA
Marketing start: 2003-04-21
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
A075232-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL			2000-01-06

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	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075232-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2000-01-06	`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: anti diarrheal
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
68467222-c8b4-4029-a180-59a57d0090d3	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
59779-960-62	anti diarrheal	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		5
59779-960-62	anti diarrheal	24 in 1 CARTON	TABLET, FILM COATED	24		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59779-960-62	EA - Each	59779-960	64923e31-f9a0-4476-a405-12a744f3a5bb	1	2021-11-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY]	1
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-960	ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY]	5	Current NDC, Legacy NDC, 2 package rows	20221027_68467222-c8b4-4029-a180-59a57d0090d3.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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive anti diarrheal	LOPERAMIDE HCL	Strategic Sourcing Services LLC	6f70564a-4400-4ed0-960b-09135a2f3a7c	2023-12-07	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
leader anti diarrheal	LOPERAMIDE HCL	Cardinal Health 110, LLC. dba Leader	6761d752-f529-41a7-9b33-73c79481d481	2021-10-07	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
basic care loperamide hydrochloride	LOPERAMIDE HCL	Amazon.com Services LLC	732edad8-9a3f-4ce0-a323-c8bffa4acb5f	2021-02-17	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
anti diarrheal	LOPERAMIDE HCL	L. Perrigo Company	e5c96703-1487-4943-9b16-fa6a05e6b02e	2019-12-17	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232
Good Sense anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Proficient Rx LP	345be8d9-4fc9-40a2-a9f3-775d48beb85b	2019-10-01	Warnings	Exact identifier application applno (ANDA): 075232 application number: ANDA075232

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	68467222-c8b4-4029-a180-59a57d0090d3	5
978010	loperamide hydrochloride 2 MG Oral Tablet	SCD	68467222-c8b4-4029-a180-59a57d0090d3	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-960-62	59779096062	24 BLISTER PACK in 1 CARTON (59779-960-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK	24 blister pack	2003-04-21	0000-00-00	No	No	Current