Home NDC 51672-1273 Fluocinonide
Product NDC 51672-1273
11-digit product format 516721273
Labeler code 51672
Product ID 51672-1273_38e4193a-b01f-02ec-e063-6394a90ab1ec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluocinonide
Dosage form SOLUTION
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA074799
Marketing category ANDA
Marketing start 1996-12-31
Substance FLUOCINONIDE
Active strength .5 mg/mL
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074799-001 FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074799-001 AT
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074799-001 FLUOCINONIDE 0.05% SOLUTION / TOPICAL AT RS 1996-12-31 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluocinonide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOCINONIDE .5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2W4A77YPAN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310364 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-1273-2 Fluocinonide 1 in 1 CARTON SOLUTION 1 8 51672-1273-2 Fluocinonide 20 mL in 1 BOTTLE, PLASTIC SOLUTION 20 8 51672-1273-4 Fluocinonide 1 in 1 CARTON SOLUTION 1 8 51672-1273-4 Fluocinonide 60 mL in 1 BOTTLE, PLASTIC SOLUTION 60 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Fluocinonide ACTIVE INGREDIENT 2W4A77YPAN FLUOCINONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 Fluocinonide ACTIVE MOIETY 2W4A77YPAN FLUOCINONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 alcohol INACTIVE INGREDIENT 3K9958V90M FLUOCINONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP FLUOCINONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 diisopropyl adipate INACTIVE INGREDIENT P7E6YFV72X FLUOCINONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 FLUOCINONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R FLUOCINONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 FLUOCINONIDE ACTIVE INGREDIENT 2W4A77YPAN FLUOCINONIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 FLUOCINONIDE ACTIVE MOIETY 2W4A77YPAN FLUOCINONIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M FLUOCINONIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP FLUOCINONIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 DIISOPROPYL ADIPATE INACTIVE INGREDIENT P7E6YFV72X FLUOCINONIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLUOCINONIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1273 FLUOCINONIDE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 Current NDC, Legacy NDC, 4 package rows 20250504_6fe14034-7703-4aa1-a029-e97c84e02430.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51672-1273-2 51672127302 1 BOTTLE, PLASTIC in 1 CARTON (51672-1273-2) / 20 mL in 1 BOTTLE, PLASTIC 1996-12-31 0000-00-00 No No Current 51672-1273-4 51672127304 1 BOTTLE, PLASTIC in 1 CARTON (51672-1273-4) / 60 mL in 1 BOTTLE, PLASTIC 1996-12-31 0000-00-00 No No Current