Spinosad

Product NDC: 28595-570
11-digit product format: 285950570
Labeler code: 28595
Product ID: 28595-570_462b23e2-dcbb-b932-e063-6294a90a2cdd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spinosad
Dosage form: SUSPENSION
Route: TOPICAL
Labeler: Allegis Pharmaceuticals, LLC
Application: NDA022408
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-06-25
Marketing end: 2027-06-30
Substance: SPINOSAD
Active strength: 9 mg/mL
Pharmacologic classes: Pediculicide [EPC]
NDC exclude flag: No
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
N022408-001	NATROBA	SPINOSAD	0.9%	SUSPENSION / TOPICAL		RLD, RS	2011-01-18

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022408-001	9895388	2033-11-25	U-3365		2022-05-19

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022408-001	NATROBA	0.9%	SUSPENSION / TOPICAL	RLD, RS	2011-01-18	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 67 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022408-001	9895388	2033-11-25	U-3365		2022-05-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022408-001	6342482	2019-06-22	U-1105	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022408-001	7030095	2021-07-02	U-1105	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022408-001	7030095	2021-07-02	U-1105	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022408-001	7030095	2021-07-02	U-1105	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022408-001	7030095	2021-07-02	U-1105	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022408-001	7030095	2021-07-02	U-1105	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022408-001	7030095	2021-07-02	U-1105	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022408-001	6342482	2019-06-22	U-1105	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022408-001	7030095	2021-07-02	U-1105	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022408-001	6342482	2019-06-22	U-1105	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022408-001	7030095	2021-07-02	U-1105	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022408-001	6063771	2023-07-25	U-1670	Drug product	2015-03-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022408-001	6342482	2019-06-22	U-1105	Drug product		`ea99ee380514…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022408-001	I-858	2024-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022408-001	I-858	2024-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022408-001	I-858	2024-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022408-001	I-858	2024-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022408-001	I-858	2024-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022408-001	I-858	2024-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022408-001	I-858	2024-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022408-001	I-858	2024-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022408-001	I-858	2024-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022408-001	I-858	2024-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022408-001	I-858	2024-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022408-001	I-858	2024-04-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022408-001	I-858	2024-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022408-001	I-858	2024-04-28	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022408-001	I-858	2024-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022408-001	I-858	2024-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022408-001	I-858	2024-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022408-001	I-858	2024-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022408-001	I-858	2024-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022408-001	I-858	2024-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022408-001	I-858	2024-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022408-001	I-858	2024-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022408-001	I-858	2024-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022408-001	I-858	2024-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022408-001	I-858	2024-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022408-001	I-858	2024-04-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022408-001	I-858	2024-04-28	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Spinosad

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SPINOSAD	9 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XPA88EAP6V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1085816	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
8e87bd3b-db25-4e97-bf57-96c875f67ce1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
51bc04ae-91cb-4b68-a5f5-55e3393918a4	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
28595-570-04	Spinosad	1 in 1 CARTON	SUSPENSION	1		9
28595-570-04	Spinosad	120 mL in 1 BOTTLE, PLASTIC	SUSPENSION	120		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
28595-570-04	ML - Milliliter	28595-570	5a66b273-4598-4d68-a4bd-964328e12202	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
spinosad	ACTIVE INGREDIENT	XPA88EAP6V	SPINOSAD SUSPENSION [ALLEGIS PHARMACEUTICALS, LLC]	2
spinosad	ACTIVE MOIETY	XPA88EAP6V	SPINOSAD SUSPENSION [ALLEGIS PHARMACEUTICALS, LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	SPINOSAD SUSPENSION [ALLEGIS PHARMACEUTICALS, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
28595-570	SPINOSAD SUSPENSION [ALLEGIS PHARMACEUTICALS, LLC]	8	Current NDC, Legacy NDC, 2 package rows	20250110_8e87bd3b-db25-4e97-bf57-96c875f67ce1.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spinosad	SPINOSAD	Cipher Pharmaceuticals Inc.	16a95039-0df7-45d5-8b51-bbc81443fea3	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022408 application number: NDA022408
Natroba	SPINOSAD	Cipher Pharmaceuticals Inc.	72cf38f4-9ef4-4b0e-b085-b02f399e2592	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022408 application number: NDA022408
Spinosad	SPINOSAD	Allegis Pharmaceuticals, LLC	8e87bd3b-db25-4e97-bf57-96c875f67ce1	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022408 application number: NDA022408 ndc (product): 28595-570
Spinosad	SPINOSAD	ParaPRO LLC	0d6e2507-3669-441e-b5ba-86087fd2955d	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022408 application number: NDA022408
Natroba	SPINOSAD	ParaPRO LLC	fa90ccc8-2df0-49f7-8878-2b33e34cd272	2021-04-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022408 application number: NDA022408

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XPA88EAP6V	SPINOSAD	168316-95-8	SPINOSAD

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1085816	spinosad 0.9 % Topical Suspension	PSN	8e87bd3b-db25-4e97-bf57-96c875f67ce1	9
1085816	spinosad 9 MG/ML Medicated Shampoo	SCD	8e87bd3b-db25-4e97-bf57-96c875f67ce1	9
1085816	spinosad 0.9 % Medicated Shampoo	SY	8e87bd3b-db25-4e97-bf57-96c875f67ce1	9
1085816	spinosad 0.9 % Topical Suspension	SY	8e87bd3b-db25-4e97-bf57-96c875f67ce1	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
28595-570-04	28595057004	1 BOTTLE, PLASTIC in 1 CARTON (28595-570-04) / 120 mL in 1 BOTTLE, PLASTIC	2014-06-25	2027-06-30	No	No	Current