Ivermectin

Product NDC: 63629-7275
Requested package NDC: 63629-7275-4
11-digit product format: 636297275
Labeler code: 63629
Product ID: 63629-7275_130bb860-3294-494c-8569-df64cf5ffc6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ivermectin
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA204154
Marketing category: ANDA
Marketing start: 2014-11-15
Marketing end: 0000-00-00
Substance: IVERMECTIN
Active strength: 3 mg/1
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	63629-7275	63629-7275-4	D	Discontinued by firm		2026-08-03

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A204154-001	IVERMECTIN	IVERMECTIN	3MG	TABLET / ORAL	AB		2014-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204154-001	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 · 41 observed 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
2026-02-19 14:30 UTC	2026-02	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204154-001	IVERMECTIN	3MG	TABLET / ORAL	AB	2014-10-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204154-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204154-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204154-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204154-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204154-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204154-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204154-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204154-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204154-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204154-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204154-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204154-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204154-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204154-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204154-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204154-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204154-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204154-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204154-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204154-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204154-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204154-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204154-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204154-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204154-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204154-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204154-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204154-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204154-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204154-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204154-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204154-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204154-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204154-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204154-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204154-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204154-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204154-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204154-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204154-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-7275-1	2020-10-16	Ivermectin Tablets USP, 3mg (IVERMECTIN)
63629-7275-2	2020-10-16	Ivermectin Tablets USP, 3mg (IVERMECTIN)
63629-7275-3	2020-10-16	Ivermectin Tablets USP, 3mg (IVERMECTIN)
63629-7275-4	2020-10-16	Ivermectin Tablets USP, 3mg (IVERMECTIN)
63629-7275-1	2020-01-31	Ivermectin Tablets USP, 3mg (IVERMECTIN)
63629-7275-2	2020-01-31	Ivermectin Tablets USP, 3mg (IVERMECTIN)
63629-7275-3	2020-01-31	Ivermectin Tablets USP, 3mg (IVERMECTIN)
63629-7275-4	2020-01-31	Ivermectin Tablets USP, 3mg (IVERMECTIN)

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ivermectin	IVERMECTIN	A-S Medication Solutions	104a5045-94b1-4022-bc49-719521f30f0d	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204154 application number: ANDA204154
Ivermectin	IVERMECTIN	Edenbridge Pharmaceuticals LLC.	847a1dd7-d65b-4a0e-a67d-d90392059dac	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204154 application number: ANDA204154
Ivermectin	IVERMECTIN	NuCare Pharmaceuticals,Inc.	ad6539f2-94de-1bc5-e053-2a95a90a4cf2	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204154 application number: ANDA204154
Ivermectin	IVERMECTIN	Asclemed USA, Inc.	014e33e7-c07d-4feb-a2cf-7cd160b1facd	2023-10-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204154 application number: ANDA204154

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
63629-7275-4	63629727504	10 TABLET in 1 BOTTLE (63629-7275-4)	10 tablet	2017-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ivermectin Tablets USP, 3mg (IVERMECTIN)	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	4