Spinosad

Product NDC
52246-570
11-digit product format
522460570
Labeler code
52246
Product ID
52246-570_f2a068ae-4f02-4647-bb8d-052f82dd8d87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spinosad
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
ParaPRO LLC
Application
NDA022408
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-01-29
Substance
SPINOSAD
Active strength
9 mg/mL
Pharmacologic classes
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022408-001NATROBASPINOSAD0.9%SUSPENSION / TOPICALRLD, RS2011-01-18

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022408-00198953882033-11-25U-33652022-05-19

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-183f01610625f2…
2019-09-15 20:21 UTC2019-09N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022408-001NATROBA0.9%SUSPENSION / TOPICALRLD, RS2011-01-18e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 2 · 67 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N022408-00198953882033-11-25U-33652022-05-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022408-00198953882033-11-25U-33652022-05-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022408-00198953882033-11-25U-33652022-05-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N022408-00198953882033-11-25U-33652022-05-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022408-00198953882033-11-25U-33652022-05-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022408-00198953882033-11-25U-33652022-05-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022408-00198953882033-11-25U-33652022-05-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022408-00198953882033-11-25U-33652022-05-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022408-00198953882033-11-25U-33652022-05-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022408-00198953882033-11-25U-33652022-05-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022408-00198953882033-11-25U-33652022-05-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022408-00198953882033-11-25U-33652022-05-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022408-00198953882033-11-25U-33652022-05-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022408-00198953882033-11-25U-33652022-05-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022408-00198953882033-11-25U-33652022-05-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022408-00160637712023-07-25U-1670Drug product2015-03-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022408-00198953882033-11-25U-33652022-05-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022408-00160637712023-07-25U-1670Drug product2015-03-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022408-00160637712023-07-25U-1670Drug product2015-03-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022408-00163424822019-06-22U-1105Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022408-00170300952021-07-02U-1105Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022408-00160637712023-07-25U-1670Drug product2015-03-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022408-00160637712023-07-25U-1670Drug product2015-03-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022408-00170300952021-07-02U-1105Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N022408-00160637712023-07-25U-1670Drug product2015-03-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022408-00170300952021-07-02U-1105Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022408-00160637712023-07-25U-1670Drug product2015-03-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N022408-00170300952021-07-02U-1105Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022408-00160637712023-07-25U-1670Drug product2015-03-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022408-00170300952021-07-02U-1105Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022408-00160637712023-07-25U-1670Drug product2015-03-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022408-00170300952021-07-02U-1105Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022408-00160637712023-07-25U-1670Drug product2015-03-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022408-00163424822019-06-22U-1105Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N022408-00170300952021-07-02U-1105Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N022408-00160637712023-07-25U-1670Drug product2015-03-243f01610625f2…
2019-09-15 20:21 UTC2019-09N022408-00163424822019-06-22U-1105Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N022408-00170300952021-07-02U-1105Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N022408-00160637712023-07-25U-1670Drug product2015-03-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N022408-00163424822019-06-22U-1105Drug productea99ee380514…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022408-001I-8582024-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022408-001I-8582024-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022408-001I-8582024-04-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022408-001I-8582024-04-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022408-001I-8582024-04-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022408-001I-8582024-04-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022408-001I-8582024-04-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022408-001I-8582024-04-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022408-001I-8582024-04-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022408-001I-8582024-04-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022408-001I-8582024-04-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022408-001I-8582024-04-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N022408-001I-8582024-04-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022408-001I-8582024-04-28782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022408-001I-8582024-04-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022408-001I-8582024-04-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022408-001I-8582024-04-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022408-001I-8582024-04-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022408-001I-8582024-04-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022408-001I-8582024-04-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022408-001I-8582024-04-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N022408-001I-8582024-04-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N022408-001I-8582024-04-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022408-001I-8582024-04-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022408-001I-8582024-04-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022408-001I-8582024-04-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022408-001I-8582024-04-28cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPINOSAD9 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XPA88EAP6VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1085816Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0d6e2507-3669-441e-b5ba-86087fd2955dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
51bc04ae-91cb-4b68-a5f5-55e3393918a4Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52246-570-04Spinosad1 in 1 CARTONSUSPENSION11
52246-570-04Spinosad120 mL in 1 BOTTLE, PLASTICSUSPENSION1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52246-570-04ML - Milliliter52246-5708bbef9b2-419a-4bbc-be23-5c061b475d3b12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52246-570SPINOSAD SUSPENSION [PARAPRO LLC]1Current NDC, 2 package rows20240201_0d6e2507-3669-441e-b5ba-86087fd2955d.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SpinosadSPINOSADCipher Pharmaceuticals Inc.16a95039-0df7-45d5-8b51-bbc81443fea32026-03-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 022408
application number: NDA022408
NatrobaSPINOSADCipher Pharmaceuticals Inc.72cf38f4-9ef4-4b0e-b085-b02f399e25922026-03-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 022408
application number: NDA022408
SpinosadSPINOSADAllegis Pharmaceuticals, LLC8e87bd3b-db25-4e97-bf57-96c875f67ce12025-12-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 022408
application number: NDA022408
SpinosadSPINOSADParaPRO LLC0d6e2507-3669-441e-b5ba-86087fd2955d2024-01-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 022408
application number: NDA022408
ndc (product): 52246-570
NatrobaSPINOSADParaPRO LLCfa90ccc8-2df0-49f7-8878-2b33e34cd2722021-04-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 022408
application number: NDA022408

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085816spinosad 0.9 % Topical SuspensionPSN0d6e2507-3669-441e-b5ba-86087fd2955d1
1085816spinosad 9 MG/ML Medicated ShampooSCD0d6e2507-3669-441e-b5ba-86087fd2955d1
1085816spinosad 0.9 % Medicated ShampooSY0d6e2507-3669-441e-b5ba-86087fd2955d1
1085816spinosad 0.9 % Topical SuspensionSY0d6e2507-3669-441e-b5ba-86087fd2955d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
52246-570-04522460570041 BOTTLE, PLASTIC in 1 CARTON (52246-570-04) / 120 mL in 1 BOTTLE, PLASTIC2024-01-29NoNoCurrent