Loperamide Hydrochloride

Product NDC: 59556-959
11-digit product format: 595560959
Labeler code: 59556
Product ID: 59556-959_2a06f8a8-0779-471c-aa1b-11abaa211f12
Type: HUMAN OTC DRUG
Nonproprietary name: Loperamide Hydrochloride
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Strides Pharma Inc
Application: ANDA213070
Marketing category: ANDA
Marketing start: 2021-10-22
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: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59556-959-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59556-959-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59556-959-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59556-959-06	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A213070-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL			2021-08-11

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213070-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	2021-08-11	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213070-001	CGT	2022-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213070-001	CGT	2022-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213070-001	CGT	2022-04-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213070-001	CGT	2022-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213070-001	CGT	2022-04-20	`782e0a99824c…`
2023-01-26 05:58 UTC	2023-01	A213070-001	CGT	2022-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213070-001	CGT	2022-04-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213070-001	CGT	2022-04-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213070-001	CGT	2022-04-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213070-001	CGT	2022-04-20	`cb3db0bc1861…`

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
4178b3cc-e1ca-4912-8b1f-eac0110a3940	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Strides Pharma, Inc.	4178b3cc-e1ca-4912-8b1f-eac0110a3940	2026-08-13	Warnings	Exact identifier application applno (ANDA): 213070 application number: ANDA213070 ndc (product): 59556-959
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	6fe91ddc-06b6-3a51-2b48-f6f11361ab73	2023-06-25	Warnings	Exact identifier application applno (ANDA): 213070 application number: ANDA213070
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	356d9432-d948-4b88-b297-9161b845f86b	2023-06-25	Warnings	Exact identifier application applno (ANDA): 213070 application number: ANDA213070

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
77TI35393C	LOPERAMIDE HYDROCHLORIDE	34552-83-5	LOPERAMIDE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59556-959-05	59556095905	2 BLISTER PACK in 1 CARTON (59556-959-05) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (59556-959-03)	2 blister pack	2021-10-22	0000-00-00	No	No	Current
59556-959-06	59556095906	1 BLISTER PACK in 1 CARTON (59556-959-06) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (59556-959-03)	1 blister pack	2021-10-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loperamide Hydrochloride Capsules USP, 2 mg, liquid filled Drug Facts	Strides Pharma, Inc. \| Onesource Softgels Pte. Ltd. \| Strides Pharma Science Limited	2026-08-13	HUMAN OTC DRUG LABEL	7