Loperamide Hydrochloride

Product NDC: 71610-648
11-digit product format: 716100648
Labeler code: 71610
Product ID: 71610-648_6971060e-f7f3-4055-837d-9c5a16e8ff6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Loperamide Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA215001
Marketing category: ANDA
Marketing start: 2020-09-25
Substance: LOPERAMIDE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A215001-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB		2021-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215001-001	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
2026-08-18 06:07:40	2026-07	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215001-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2021-10-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215001-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215001-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215001-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215001-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215001-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215001-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215001-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215001-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215001-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215001-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215001-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215001-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215001-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215001-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215001-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215001-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215001-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215001-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215001-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215001-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215001-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215001-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215001-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215001-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215001-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215001-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215001-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215001-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215001-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215001-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215001-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215001-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215001-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215001-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Loperamide Hydrochloride
Listing expiration: 2026-12-31

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
4d69532c-c71a-4880-9f74-4b37d912cabd	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
71610-648-53	Loperamide Hydrochloride	60 in 1 BOTTLE	CAPSULE	60		2
71610-648-60	Loperamide Hydrochloride	90 in 1 BOTTLE	CAPSULE	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-648-53	EA - Each	71610-648	f4674958-bfde-4432-97a4-8476dc699f70	1	2022-07-06
71610-648-60	EA - Each	71610-648	185a0499-0e68-4994-943b-bc9d32ac9cd9	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-648	LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20220512_4d69532c-c71a-4880-9f74-4b37d912cabd.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	1e9dfe71-28a9-4b54-a0e1-7c0d82fec0d7	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215001 application number: ANDA215001
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Golden State Medical Supply, Inc.	396f7e13-b357-52be-e063-6394a90a92fc	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215001 application number: ANDA215001
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Edenbridge Pharmaceuticals LLC.	d92819f1-d02d-4959-a019-17d44df6ed2f	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215001 application number: ANDA215001
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3f031dfb-be55-5a44-e063-6394a90aeec5	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215001 application number: ANDA215001
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	allphamed Pharbil Arzneimittel GmbH	a8c8d1d2-a8c7-462a-b620-729a9baa93c4	2023-02-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215001 application number: ANDA215001
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4d69532c-c71a-4880-9f74-4b37d912cabd	2022-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215001 application number: ANDA215001 ndc (product): 71610-648

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	4d69532c-c71a-4880-9f74-4b37d912cabd	2
978006	loperamide hydrochloride 2 MG Oral Capsule	SCD	4d69532c-c71a-4880-9f74-4b37d912cabd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-648-53	71610064853	60 CAPSULE in 1 BOTTLE (71610-648-53)	60 capsule	2022-05-02	0000-00-00	No	No	Current
71610-648-60	71610064860	90 CAPSULE in 1 BOTTLE (71610-648-60)	90 capsule	2022-05-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loperamide Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2022-05-11	Human Prescription Drug Label	2