Ivermectin

Product NDC: 46122-827
11-digit product format: 461220827
Labeler code: 46122
Product ID: 46122-827_4f9549d0-8c2f-d3b3-e063-6294a90aec31
Type: HUMAN OTC DRUG
Nonproprietary name: Ivermectin
Dosage form: LOTION
Route: TOPICAL
Labeler: AmerisourceBergen
Application: ANDA210720
Marketing category: ANDA
Marketing start: 2026-04-03
Substance: IVERMECTIN
Active strength: 5 mg/g
Pharmacologic classes: Antiparasitic [EPC], Pediculicide [EPC]
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
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
2026-08-18 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ivermectin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IVERMECTIN	5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8883YP2R6D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1246673	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
4e924212-cd7b-ccd9-e063-6394a90afb95	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7fd951fe-040a-0b64-2bea-eefc6aa4fc54	Product name	2	20250515
5b0ed980-56ce-7dd0-fb86-ff54be67c2e6	Product name	2	20200925
eed31638-1288-4eb6-a55c-5fc014dca98d	Product name	3	20200728
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46122-827-36	Ivermectin	117 g in 1 TUBE	LOTION	117		2
46122-827-36	Ivermectin	1 in 1 CARTON	LOTION	1		2

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	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 ndc (product): 46122-827
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
Ivermectin	IVERMECTIN	CVS Pharmacy	15f1fe25-8ac4-486c-926d-86da187f5efc	2021-12-30	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1246673	ivermectin 0.5 % Topical Lotion	PSN	4e924212-cd7b-ccd9-e063-6394a90afb95	2
1246673	ivermectin 5 MG/ML Topical Lotion	SCD	4e924212-cd7b-ccd9-e063-6394a90afb95	2
1246673	ivermectin 0.5 % Topical Lotion	SY	4e924212-cd7b-ccd9-e063-6394a90afb95	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
46122-827-36	46122082736	1 TUBE in 1 CARTON (46122-827-36) / 117 g in 1 TUBE	1 tube	2026-04-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GNP Ivermectin Lotion, 0.5%	AmerisourceBergen \| Taro Pharmaceutical Industries Ltd.	2026-04-16	HUMAN OTC DRUG LABEL	2