Griseofulviin (microsize)

Product NDC
42254-306
11-digit product format
422540306
Labeler code
42254
Product ID
42254-306_f1153794-33ae-4e9d-8c80-d29e01f82d77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Griseofulvin (microsize)
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA065394
Marketing category
ANDA
Marketing start
2007-07-26
Marketing end
0000-00-00
Substance
GRISEOFULVIN
Active strength
125 mg/5mL
Pharmacologic classes
Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42254-306IInactivated by FDA2026-08-11
excluded packagepackage42254-30642254-306-04IInactivated by FDA2026-08-11

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42254-306-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42254-306-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42254-306-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42254-306-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42254-306-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42254-306-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42254-306-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42254-306-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42254-306-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42254-306-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42254-306-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42254-306-04557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42254-306-048af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42254-306-04834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42254-306-041332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42254-306-04fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42254-306-0486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42254-306-04bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42254-306-048dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42254-306-04e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42254-306-049bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42254-306-04110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065394-001GRISEOFULVINGRISEOFULVIN, MICROSIZE125MG/5MLSUSPENSION / ORALABRS2007-07-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065394-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-063f01610625f2…
2019-09-15 20:21 UTC2019-09A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065394-001GRISEOFULVIN125MG/5MLSUSPENSION / ORALABRS2007-07-06cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065394-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065394-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065394-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065394-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065394-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065394-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065394-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065394-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065394-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065394-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065394-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065394-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065394-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065394-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065394-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065394-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065394-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065394-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065394-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065394-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065394-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065394-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065394-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065394-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065394-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065394-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065394-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065394-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065394-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065394-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065394-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065394-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065394-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065394-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065394-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065394-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065394-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065394-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065394-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065394-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
50874f84-35e6-097e-94d8-7241c05d199fProduct name220190416
024bc7a6-8e89-3d87-480f-f3ffc8f2ad80Product name120140508
0b9696ae-027f-1570-8c58-4178203eb52bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-306-042019-09-24C16284748780-19350213a-3d22-c013-e053-90daa90a1393GRISEOFULVIN ORAL SUSPENSION (microsize) USP, 125 mg/5 mL Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-306-04Griseofulviin (microsize)120 mL in 1 BOTTLESUSPENSION1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-306-04ML - Milliliter42254-30693b80ded-fc2a-4648-8e4c-511b7328605112013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GRISEOFULVINACTIVE INGREDIENT32HRV3E3D5GRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
GRISEOFULVINACTIVE MOIETY32HRV3E3D5GRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0GRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554GRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RGRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-306GRISEOFULVIIN (MICROSIZE) (GRISEOFULVIN (MICROSIZE)) SUSPENSION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20130221_f1153794-33ae-4e9d-8c80-d29e01f82d77.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GriseofulvinGRISEOFULVINActavis Pharma, Inc.af318d5d-cc39-4a63-a590-b87c50f2694f2023-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065394
application number: ANDA065394

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239238griseofulvin 125 MG in 5 mL Oral SuspensionPSNf1153794-33ae-4e9d-8c80-d29e01f82d771
239238griseofulvin 25 MG/ML Oral SuspensionSCDf1153794-33ae-4e9d-8c80-d29e01f82d771
239238griseofulvin 125 MG per 5 ML Oral SuspensionSYf1153794-33ae-4e9d-8c80-d29e01f82d771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42254-306-0442254030604120 mL in 1 BOTTLE120 mlHistorical