Fluocinonide

Product NDC
51672-1386
11-digit product format
516721386
Labeler code
51672
Product ID
51672-1386_3972605f-b081-0289-e063-6294a90ab0e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA071500
Marketing category
ANDA
Marketing start
2016-10-27
Substance
FLUOCINONIDE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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
A071500-001FLUOCINONIDEFLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071500-001AB1

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 06:07:402026-07A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-103f01610625f2…
2019-09-15 20:21 UTC2019-09A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071500-001FLUOCINONIDE0.05%CREAM / TOPICALAB11987-06-10e64feba35796…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A071500-001AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071500-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071500-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071500-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071500-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071500-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071500-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071500-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071500-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071500-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071500-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071500-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071500-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071500-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071500-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071500-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071500-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071500-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071500-001AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071500-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071500-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071500-001AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A071500-001AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071500-001AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071500-001AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071500-001AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A071500-001AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A071500-001AB11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071500-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071500-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071500-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071500-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071500-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071500-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071500-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A071500-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A071500-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071500-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071500-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071500-001AB11e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINONIDE.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2W4A77YPANInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
103456Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5782d791-48fd-4cee-853d-235eb4d04a40Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
a338afdd-91bc-4c45-5113-8b445b8e6cf2Product name520200618
f3bf4e6e-291f-4372-8e90-b4047949153aProduct name320200514
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
934e8c63-e34a-6dfb-4224-efad2d76fafcProduct name520190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfeProduct name120181219
ef1d202f-16bf-4f17-a390-087db27f5314Product name120181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1386-1Fluocinonide15 g in 1 TUBECREAM153
51672-1386-1Fluocinonide1 in 1 CARTONCREAM13
51672-1386-2Fluocinonide30 g in 1 TUBECREAM303
51672-1386-2Fluocinonide1 in 1 CARTONCREAM13
51672-1386-3Fluocinonide60 g in 1 TUBECREAM603
51672-1386-3Fluocinonide1 in 1 CARTONCREAM13
51672-1386-4Fluocinonide120 g in 1 TUBECREAM1203
51672-1386-4Fluocinonide1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1386-1GM - Gram51672-138694eaa54a-220f-4e16-a8cb-eb3c6fd2a84e12017-04-05
51672-1386-2GM - Gram51672-1386e709049c-b525-42c0-9c77-65fd58599d8f12017-04-05
51672-1386-3GM - Gram51672-138656fc2100-c2f3-4fc5-9602-8739f611c56812017-04-05
51672-1386-4GM - Gram51672-138673d0a0da-2a64-4d2b-be5a-dfdfa3e5a4a212017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1386FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1Current NDC, Legacy NDC, 8 package rows20161118_5782d791-48fd-4cee-853d-235eb4d04a40.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluocinonideFLUOCINONIDEA-S Medication Solutionsa2e8aa7a-8996-4dc8-a36b-e8c29fb8540e2025-12-06Adverse reactionsExact identifier
application applno (ANDA): 071500
application number: ANDA071500
FluocinonideFLUOCINONIDESun Pharmaceutical Industries, Inc.5782d791-48fd-4cee-853d-235eb4d04a402025-07-08Adverse reactionsExact identifier
application applno (ANDA): 071500
application number: ANDA071500
ndc (product): 51672-1386
FluocinonideFLUOCINONIDENuCare Pharmaceuticals,Inc.8ac0ecd6-38b5-a5f9-e053-2a95a90af4122024-06-14Adverse reactionsExact identifier
application applno (ANDA): 071500
application number: ANDA071500
FluocinonideFLUOCINONIDENuCare Pharmaceuticals Inc.624c81a7-282a-95be-e053-2991aa0a6b442024-06-06Adverse reactionsExact identifier
application applno (ANDA): 071500
application number: ANDA071500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103456fluocinonide 0.05 % Topical CreamPSNa2e8aa7a-8996-4dc8-a36b-e8c29fb8540e13
103456fluocinonide 0.5 MG/ML Topical CreamSCDa2e8aa7a-8996-4dc8-a36b-e8c29fb8540e13
103456fluocinonide 0.05 % Topical CreamSYa2e8aa7a-8996-4dc8-a36b-e8c29fb8540e13
103456fluocinonide 0.05 % Topical CreamPSN624c81a7-282a-95be-e053-2991aa0a6b444
103456fluocinonide 0.5 MG/ML Topical CreamSCD624c81a7-282a-95be-e053-2991aa0a6b444
103456fluocinonide 0.05 % Topical CreamSY624c81a7-282a-95be-e053-2991aa0a6b444
103456fluocinonide 0.05 % Topical CreamPSN5782d791-48fd-4cee-853d-235eb4d04a403
103456fluocinonide 0.05 % Topical CreamPSN8ac0ecd6-38b5-a5f9-e053-2a95a90af4123
103456fluocinonide 0.5 MG/ML Topical CreamSCD5782d791-48fd-4cee-853d-235eb4d04a403
103456fluocinonide 0.5 MG/ML Topical CreamSCD8ac0ecd6-38b5-a5f9-e053-2a95a90af4123
103456fluocinonide 0.05 % Topical CreamSY5782d791-48fd-4cee-853d-235eb4d04a403
103456fluocinonide 0.05 % Topical CreamSY8ac0ecd6-38b5-a5f9-e053-2a95a90af4123
103456fluocinonide 0.05 % Topical CreamPSNd823803c-a125-4695-a04b-6c14b6a66ab61
103456fluocinonide 0.05 % Topical CreamPSN1f1b7129-3eda-8dae-e063-6394a90aa7751
103456fluocinonide 0.5 MG/ML Topical CreamSCDd823803c-a125-4695-a04b-6c14b6a66ab61
103456fluocinonide 0.5 MG/ML Topical CreamSCD1f1b7129-3eda-8dae-e063-6394a90aa7751
103456fluocinonide 0.05 % Topical CreamSY1f1b7129-3eda-8dae-e063-6394a90aa7751
103456fluocinonide 0.05 % Topical CreamSYd823803c-a125-4695-a04b-6c14b6a66ab61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1386-1516721386011 TUBE in 1 CARTON (51672-1386-1) / 15 g in 1 TUBE1 tube2016-10-270000-00-00NoNoCurrent
51672-1386-2516721386021 TUBE in 1 CARTON (51672-1386-2) / 30 g in 1 TUBE1 tube2016-10-270000-00-00NoNoCurrent
51672-1386-3516721386031 TUBE in 1 CARTON (51672-1386-3) / 60 g in 1 TUBE1 tube2016-10-270000-00-00NoNoCurrent
51672-1386-4516721386041 TUBE in 1 CARTON (51672-1386-4) / 120 g in 1 TUBE1 tube2016-10-270000-00-00NoNoCurrent