STROMECTOL

Product NDC: 0006-0032
11-digit product format: 000060032
Labeler code: 0006
Product ID: 0006-0032_21f446cf-c0bf-48a5-a535-9d376bc365a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ivermectin
Dosage form: TABLET
Route: ORAL
Labeler: Merck Sharp & Dohme LLC
Application: NDA050742
Marketing category: NDA
Marketing start: 1996-11-22
Substance: IVERMECTIN
Active strength: 3 mg/1
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 45.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050742-001	STROMECTOL	IVERMECTIN	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22
N050742-002	STROMECTOL	IVERMECTIN	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050742-002	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 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050742-001	STROMECTOL	6MG	TABLET / ORAL		RLD	1996-11-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`5d02ea3f76ae…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	N050742-002	AB	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N050742-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050742-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050742-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050742-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050742-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050742-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050742-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050742-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050742-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050742-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050742-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050742-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050742-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050742-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050742-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050742-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050742-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050742-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050742-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050742-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050742-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050742-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050742-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050742-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050742-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050742-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050742-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050742-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050742-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050742-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050742-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050742-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050742-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050742-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050742-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050742-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050742-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050742-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050742-002	AB	1	`3bdfa0b2c4d7…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IVERMECTIN	3 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
261314	Internal RxNorm lookup
311207	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
681888c9-af79-4b7d-ae80-c3f4f6f1effd	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0006-0032-01	STROMECTOL	10 in 1 BLISTER PACK	TABLET	10	20
0006-0032-01	STROMECTOL	2 in 1 CARTON	TABLET	2	20
0006-0032-20	STROMECTOL	10 in 1 BLISTER PACK	TABLET	10	20
0006-0032-20	STROMECTOL	2 in 1 CARTON	TABLET	2	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-0032-01	EA - Each	0006-0032	b7f689df-5615-45b8-977c-d760437b6b25	1	2025-07-08
0006-0032-20	EA - Each	0006-0032	a1494d7a-4b37-4e95-b6d9-1b0d58b30882	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IVERMECTIN	ACTIVE INGREDIENT	8883YP2R6D	STROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME CORP.]	10
IVERMECTIN	ACTIVE MOIETY	8883YP2R6D	STROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME CORP.]	10
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	STROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME CORP.]	10
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	STROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME CORP.]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	STROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME CORP.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	STROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME CORP.]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	STROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME CORP.]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0006-0032	STROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME LLC]	20	Current NDC, Legacy NDC, 4 package rows	20250424_681888c9-af79-4b7d-ae80-c3f4f6f1effd.zip

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
311207	ivermectin 3 MG Oral Tablet	PSN	681888c9-af79-4b7d-ae80-c3f4f6f1effd	20
261314	Stromectol 3 MG Oral Tablet	PSN	681888c9-af79-4b7d-ae80-c3f4f6f1effd	20
261314	ivermectin 3 MG Oral Tablet [Stromectol]	SBD	681888c9-af79-4b7d-ae80-c3f4f6f1effd	20
311207	ivermectin 3 MG Oral Tablet	SCD	681888c9-af79-4b7d-ae80-c3f4f6f1effd	20
261314	Stromectol 3 MG Oral Tablet	SY	681888c9-af79-4b7d-ae80-c3f4f6f1effd	20
311207	ivermectin 3 MG Oral Tablet	PSN	5d140f06-e46b-4cdd-97e4-37b6cf4ade13	12
261314	Stromectol 3 MG Oral Tablet	PSN	5d140f06-e46b-4cdd-97e4-37b6cf4ade13	12
261314	ivermectin 3 MG Oral Tablet [Stromectol]	SBD	5d140f06-e46b-4cdd-97e4-37b6cf4ade13	12
311207	ivermectin 3 MG Oral Tablet	SCD	5d140f06-e46b-4cdd-97e4-37b6cf4ade13	12
261314	Stromectol 3 MG Oral Tablet	SY	5d140f06-e46b-4cdd-97e4-37b6cf4ade13	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0006-0032-01	00006003201	2 BLISTER PACK in 1 CARTON (0006-0032-01) / 10 TABLET in 1 BLISTER PACK	2 blister pack	2024-09-20		No	No	Current
0006-0032-20	00006003220	2 BLISTER PACK in 1 CARTON (0006-0032-20) / 10 TABLET in 1 BLISTER PACK	2 blister pack	1996-11-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
STROMECTOL ® (IVERMECTIN) TABLETS	Merck Sharp & Dohme LLC	2024-09-20	HUMAN PRESCRIPTION DRUG LABEL	21
STROMECTOL® (IVERMECTIN) TABLETS	Department of State Health Services, Pharmacy Branch	2016-03-11	HUMAN PRESCRIPTION DRUG LABEL	12