Loperamide Hydrochloride

Product NDC: 67296-0346
11-digit product format: 672960346
Labeler code: 67296
Product ID: 67296-0346_d5fc0481-fea4-a7bf-e053-2995a90a1620
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Loperamide Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA073192
Marketing category: ANDA
Marketing start: 2011-01-01
Marketing end: 0000-00-00
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	67296-0346		I	Inactivated by FDA		2026-08-11
excluded package	package	67296-0346	67296-0346-1	I	Inactivated by FDA		2026-08-11

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-0346-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-0346-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-0346-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-0346-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A073192-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB		1992-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073192-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073192-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	1992-04-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A073192-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073192-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073192-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073192-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073192-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073192-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073192-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073192-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073192-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073192-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073192-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073192-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073192-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073192-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073192-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073192-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073192-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073192-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073192-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073192-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073192-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073192-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073192-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073192-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073192-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073192-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073192-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073192-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073192-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073192-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073192-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073192-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073192-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073192-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073192-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073192-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073192-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073192-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073192-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073192-001	AB	1	`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
67296-0346-1	2024-06-19	C162847	48780-1	1030e365-26b2-111a-e063-dadaa90a10e2	3fcb106c-f72e-17d9-e054-00144ff8d46c
67296-0346-1	2024-01-30	C162847	48780-1	1030e365-26b2-111a-e063-dadaa90a10e2	3fcb106c-f72e-17d9-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-0346-1	Loperamide Hydrochloride	15 in 1 BOTTLE	CAPSULE	15		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0346	LOPERAMIDE HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.]	5	Legacy NDC, 1 package rows	20240620_3fcb106c-f72e-17d9-e054-00144ff8d46c.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 · 10 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	ca8de42f-8aea-4e35-ab3a-75ecea718f4f	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	45a1e6b0-1e2b-958a-e063-6394a90a261d	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	American Health Packaging	42989f90-8ff5-44d1-a462-28c18ce02738	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3310a3c2-389a-4b27-a478-67c905789854	2025-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	580e6cd4-3f05-4996-9dc3-c50d757ae210	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	A-S Medication Solutions	97c37571-9116-40d6-ba07-f4a5a8d9b689	2025-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	865cf4c7-f643-451b-b0d4-d30bda621f7d	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3e898141-8d40-49f1-e054-00144ff88e88	2024-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	af0b886f-c065-26dc-e053-2995a90ac471	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	8bf47ac3-746f-47c3-82b2-32ac979ff963	2016-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073192 application number: ANDA073192

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
978006	loperamide HCl 2 MG Oral Capsule	PSN	3fcb106c-f72e-17d9-e054-00144ff8d46c	5
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	3fcb106c-f72e-17d9-e054-00144ff8d46c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-0346-1	67296034601	15 CAPSULE in 1 BOTTLE (67296-0346-1)	15 capsule	2011-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loperamide Hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	5