Loperamide Hydrochloride

Product NDC: 68071-2863
11-digit product format: 680712863
Labeler code: 68071
Product ID: 68071-2863_ebf2b303-6368-a27f-e053-2995a90a5a35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: loperamide hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA215579
Marketing category: ANDA
Marketing start: 2021-12-01
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68071-2863		I	Inactivated by FDA	2026-08-07
excluded package	package	68071-2863	68071-2863-4	I	Inactivated by FDA	2026-08-07
excluded package	package	68071-2863	68071-2863-6	I	Inactivated by FDA	2026-08-07

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 · 27 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2863-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2863-4	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2863-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2863-4	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2863-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2863-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2863-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2863-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2863-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2863-4	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2863-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2863-4	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2863-4	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2863-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2863-4	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2863-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2863-4	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2863-6	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A215579-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB		2021-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215579-001	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.

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	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215579-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215579-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215579-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215579-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215579-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215579-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215579-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215579-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215579-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215579-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215579-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215579-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215579-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215579-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215579-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215579-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215579-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215579-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215579-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215579-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215579-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215579-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215579-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215579-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215579-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215579-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215579-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215579-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215579-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215579-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215579-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215579-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215579-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215579-001	AB	1	`a50c72e98297…`

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
68071-2863-4	2025-01-30	C162847	48780-1	2cef2736-a8fe-d83d-e063-dadaa90ab31f	Loperamide Hydrochloride Capsules, USP Rx only
68071-2863-6	2025-01-30	C162847	48780-1	2cef2736-a8fe-d83d-e063-dadaa90ab31f	Loperamide Hydrochloride Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2863-4	Loperamide Hydrochloride	4 in 1 BOTTLE, PLASTIC	CAPSULE	4		2
68071-2863-6	Loperamide Hydrochloride	60 in 1 BOTTLE, PLASTIC	CAPSULE	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2863	LOPERAMIDE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]	2	Legacy NDC, 2 package rows	20230919_ebf2b8c1-dba6-12ba-e053-2995a90a4a4f.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	AvPAK	f8992723-dd9a-bcf6-e053-6294a90aa65c	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215579 application number: ANDA215579
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	df4e7076-fd25-aeb8-e053-2995a90a2aa0	2024-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215579 application number: ANDA215579
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	691c5dd6-b85d-482b-a8c1-8c4b48b48dc9	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215579 application number: ANDA215579
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bionpharma Inc.	6e60cb25-6af9-4f17-b740-a5e7b5bb2a09	2023-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215579 application number: ANDA215579

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	ebf2b8c1-dba6-12ba-e053-2995a90a4a4f	2
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	ebf2b8c1-dba6-12ba-e053-2995a90a4a4f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2863-4	68071286304	4 CAPSULE in 1 BOTTLE, PLASTIC (68071-2863-4)	4 capsule	2022-10-26	0000-00-00	No	No	Current
68071-2863-6	68071286306	60 in 1 BOTTLE, PLASTIC						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loperamide Hydrochloride Capsules, USP Rx only	NuCare Pharmaceuticals,Inc.	2023-09-18	HUMAN PRESCRIPTION DRUG LABEL	2