Ivermectin

Product NDC: 51672-4211
Requested package NDC: 51672-4211-8
11-digit product format: 516724211
Labeler code: 51672
Product ID: 51672-4211_92921d55-1976-4d38-8e19-5c1705f052b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ivermectin
Dosage form: LOTION
Route: TOPICAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA210720
Marketing category: ANDA
Marketing start: 2020-05-06
Marketing end: 0000-00-00
Substance: IVERMECTIN
Active strength: 5 mg/g
Pharmacologic classes: Antiparasitic [EPC],Pediculicide [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51672-4211	51672-4211-8	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210720-001	IVERMECTIN	IVERMECTIN	0.5%	LOTION / TOPICAL			2020-05-06

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
2026-09-14 22:38:34	2026-08	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL	AB	2020-05-06	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210720-001	IVERMECTIN	0.5%	LOTION / TOPICAL		2020-05-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A210720-001	AB	1	`c0c555d07b60…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A210720-001	PC	2021-05-29	`782e0a99824c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4211-8	GM - Gram	51672-4211	f803a15e-1fab-4857-b332-a4461dfedf3e	1	2021-01-08

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
Ivermectin	IVERMECTIN	YYBA Corp	59ea9767-2e0b-ebc2-e063-6294a90ab904	2026-08-25	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720
Ivermectin	IVERMECTIN	Azurity Pharmaceuticals, Inc.	58c9cc4d-b1f3-1b6f-e063-6294a90ab597	2026-08-11	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720
Ivermectin	IVERMECTIN	AmerisourceBergen	4e924212-cd7b-ccd9-e063-6394a90afb95	2026-04-16	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720
Ivermectin	IVERMECTIN	Sun Pharmaceutical Industries, Inc.	dd2c66e6-bd50-46df-a335-26215d02d13b	2025-12-22	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720
Ivermectin	IVERMECTIN	CVS Pharmacy	326e85c6-b95f-6aa8-e063-6294a90a4985	2025-06-20	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720
RID One and Done	IVERMECTIN	Oystershell Consumer Health, Inc.	731a15f8-3578-4a95-b04c-aa6cf44a4665	2025-03-07	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720
Ivermectin	IVERMECTIN	WALMART INC.	1608ec4a-2af4-4a43-a83f-5b25937068d1	2025-01-09	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720
Ivermectin	IVERMECTIN	Belmora LLC	0d405318-3db5-41b6-a248-a6c1cfe7a765	2024-10-17	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720
Ivermectin	IVERMECTIN	Rite Aid Corporation	3a2eb7f3-b72b-435c-a609-ce7050cccff4	2024-08-12	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720
Ivermectin	IVERMECTIN	Walgreen Company	b8e1d919-ba66-4dc0-b0fc-cfb3a229dad9	2022-01-04	Warnings	Exact identifier application applno (ANDA): 210720 application number: ANDA210720

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8883YP2R6D	IVERMECTIN	70288-86-7	IVERMECTIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4211-8	51672421108	1 TUBE in 1 CARTON (51672-4211-8) > 117 g in 1 TUBE	1 tube	2020-05-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ivermectin	Taro Pharmaceuticals U.S.A., Inc. \| Taro Pharmaceutical Industries, Ltd.	2020-05-11	HUMAN PRESCRIPTION DRUG LABEL	1