Loperamide Hydrochloride

Product NDC: 48433-063
11-digit product format: 484330063
Labeler code: 48433
Product ID: 48433-063_4d687fd6-665b-2ba8-e063-6294a90ac6bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: loperamide hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Safecor Health LLC
Application: ANDA072741
Marketing category: ANDA
Marketing start: 2026-03-06
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 42.

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
A072741-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072741-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072741-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	RS	1991-09-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A072741-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072741-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072741-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072741-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072741-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072741-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072741-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072741-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072741-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072741-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072741-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072741-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072741-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072741-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072741-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072741-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072741-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072741-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072741-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072741-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072741-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072741-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072741-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072741-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072741-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072741-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072741-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072741-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072741-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072741-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072741-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072741-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072741-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072741-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072741-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072741-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072741-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072741-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072741-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072741-001	AB	1	`e64feba35796…`

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
978006	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
8b0ac05b-90c1-476b-b001-5801dd21701d	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
48433-063-01	Loperamide Hydrochloride	1 in 1 BLISTER PACK	CAPSULE	1		3
48433-063-20	Loperamide Hydrochloride	100 in 1 CARTON	CAPSULE	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
48433-063-20	EA - Each	48433-063	4b519fea-c4ba-4eeb-8e59-d0c91851460f	1	2026-05-22

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 · 7 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	be99224e-dd49-4628-a5bf-ed8469ffd4a4	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Cardinal Health 107, LLC	74b9893a-18c3-4117-85c2-edab8e7b3b3b	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Safecor Health LLC	8b0ac05b-90c1-476b-b001-5801dd21701d	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741 ndc (product): 48433-063
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Mylan Institutional Inc.	ad71d4ab-d293-47a2-8f3f-2c9f42d76e40	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c5322892-cb14-4a25-9b42-e62e491bc101	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	f092b8a5-80b0-40ba-af45-2ac9edaa7704	2023-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	72a7ae47-cdf3-4949-b9f8-f29b153f787f	2022-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072741 application number: ANDA072741

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	8b0ac05b-90c1-476b-b001-5801dd21701d	3
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	8b0ac05b-90c1-476b-b001-5801dd21701d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
48433-063-01	48433006301	1 in 1 BLISTER PACK					Historical
48433-063-20	48433006320	100 BLISTER PACK in 1 CARTON (48433-063-20) / 1 CAPSULE in 1 BLISTER PACK (48433-063-01)	100 blister pack	2026-03-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loperamide Hydrochloride - Cardinal Health 107, LLC	Cardinal Health 107, LLC	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	1
Loperamide Hydrochloride - Safecor Health LLC	Safecor Health LLC	2026-03-19	HUMAN PRESCRIPTION DRUG LABEL	3