Griseofulvin

Product NDC
0472-0013
11-digit product format
004720013
Labeler code
0472
Product ID
0472-0013_ffdfb856-e4f1-41de-837b-a773b1f6eaf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Griseofulvin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA065394
Marketing category
ANDA
Marketing start
2007-07-26
Substance
GRISEOFULVIN
Active strength
125 mg/5mL
Pharmacologic classes
Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [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 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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GRISEOFULVIN125 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
32HRV3E3D5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
239238Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
af318d5d-cc39-4a63-a590-b87c50f2694fAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0472-0013-04Griseofulvin120 mL in 1 BOTTLESUSPENSION12017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0013-04ML - Milliliter0472-00135a56a5f4-0426-4033-a352-138ca12960ba12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GRISEOFULVINACTIVE INGREDIENT32HRV3E3D5GRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
GRISEOFULVINACTIVE MOIETY32HRV3E3D5GRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0GRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
MENTHOLINACTIVE INGREDIENTL7T10EIP3AGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
SUCROSEINACTIVE INGREDIENTC151H8M554GRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
WATERINACTIVE INGREDIENT059QF0KO0RGRISEOFULVIN SUSPENSION [ACTAVIS MID ATLANTIC LLC]6
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
0472-0013GRISEOFULVIN SUSPENSION [ACTAVIS PHARMA, INC.]16Current NDC, Legacy NDC, 1 package rows20241228_af318d5d-cc39-4a63-a590-b87c50f2694f.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
ndc (product): 0472-0013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239238griseofulvin 125 MG in 5 mL Oral SuspensionPSNaf318d5d-cc39-4a63-a590-b87c50f2694f17
239238griseofulvin 25 MG/ML Oral SuspensionSCDaf318d5d-cc39-4a63-a590-b87c50f2694f17
239238griseofulvin 125 MG per 5 ML Oral SuspensionSYaf318d5d-cc39-4a63-a590-b87c50f2694f17
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0013-0400472001304120 mL in 1 BOTTLE (0472-0013-04) 120 ml2007-07-260000-00-00NoNoCurrent