STROMECTOL

Product NDC: 0006-0032
11-digit product format: 000060032
Labeler code: 0006
Product ID: 0006-0032_200e22cc-3187-4a71-b8e1-73d90edab8bf
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: 2026-12-31
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 · 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N050742-001	STROMECTOL	IVERMECTIN	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22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 · 84 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
2026-08-18 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N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`caaa826d4ba7…`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UTC	2026-02	N050742-001	STROMECTOL	6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-11-22	`011fe1cb6892…`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…`
2022-04-04 05:41 UTC	2022-04	N050742-001	STROMECTOL	6MG	TABLET / ORAL		RLD	1996-11-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050742-001	STROMECTOL	6MG	TABLET / ORAL			1996-11-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050742-002	STROMECTOL	3MG	TABLET / ORAL	AB	RLD, RS	1998-10-08	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050742-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050742-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050742-002	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: STROMECTOL
Listing expiration: 2026-12-31

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
STROMECTOL	IVERMECTIN	Merck Sharp & Dohme LLC	681888c9-af79-4b7d-ae80-c3f4f6f1effd	2024-09-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050742 application number: NDA050742 ndc (product): 0006-0032

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 \| Merck Sharp & Dohme BV	2024-09-20	HUMAN PRESCRIPTION DRUG LABEL	20
STROMECTOL® (IVERMECTIN) TABLETS	Department of State Health Services, Pharmacy Branch	2016-03-11	HUMAN PRESCRIPTION DRUG LABEL	12