Sulconazole Nitrate

Product NDC
72143-311
11-digit product format
721430311
Labeler code
72143
Product ID
72143-311_29f5c965-1a31-83b6-e063-6394a90adc49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
JG Pharma
Application
NDA018737
Marketing category
NDA
Marketing start
2020-02-04
Substance
SULCONAZOLE NITRATE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
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
N018737-001EXELDERMSULCONAZOLE NITRATE1%CREAM / TOPICALRLD, RS1989-02-28

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 UTC2026-02N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-283f01610625f2…
2019-09-15 20:21 UTC2019-09N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018737-001EXELDERM1%CREAM / TOPICALRLD, RS1989-02-28cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULCONAZOLE NITRATE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1T89100D5UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
106366Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b731aa0-fb3f-4a96-9034-636138cbca03Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
312a1339-2d03-1da9-f090-a47730c5330aProduct name120140508
a4a028cc-e548-445b-8dc3-ebf42e7603dbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72143-311-60Sulconazole Nitrate60 g in 1 TUBECREAM602
72143-311-60Sulconazole Nitrate1 in 1 CARTONCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72143-311-60GM - Gram72143-311a27eaeee-7030-4205-8580-0107185a426b12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72143-311SULCONAZOLE NITRATE CREAM [JG PHARMA]2Current NDC, Legacy NDC, 2 package rows20241225_5b731aa0-fb3f-4a96-9034-636138cbca03.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulconazole NitrateSULCONAZOLE NITRATEJG Pharma5b731aa0-fb3f-4a96-9034-636138cbca032024-12-23Adverse reactionsExact identifier
application applno (NDA): 018737
application number: NDA018737
ndc (product): 72143-311
ExeldermSULCONAZOLE NITRATEJourney Medical Corporation1d822e06-f37e-4984-8365-efd4c44514782022-07-19Adverse reactionsExact identifier
application applno (NDA): 018737
application number: NDA018737

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106366sulconazole nitrate 1 % Topical CreamPSN5b731aa0-fb3f-4a96-9034-636138cbca032
106366sulconazole nitrate 10 MG/ML Topical CreamSCD5b731aa0-fb3f-4a96-9034-636138cbca032
106366sulconazole nitrate 1 % Topical CreamSY5b731aa0-fb3f-4a96-9034-636138cbca032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72143-311-60721430311601 TUBE in 1 CARTON (72143-311-60) / 60 g in 1 TUBE1 tube2020-02-040000-00-00NoNoCurrent