NYSTATIN AND TRIAMCINOLONE ACETONIDE

Product NDC
72162-1433
Requested package NDC
72162-1433-2
11-digit product format
721621433
Labeler code
72162
Product ID
72162-1433_3492b828-cb5a-c5d3-e063-6294a90a4da6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin, triamcinolone acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA208479
Marketing category
ANDA
Marketing start
2017-11-27
Substance
NYSTATIN; TRIAMCINOLONE ACETONIDE
Active strength
100000; 1 [USP'U]/g; mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [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
A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN; TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208479-001AT

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 UTC2026-02A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-143f01610625f2…
2019-09-15 20:21 UTC2019-09A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208479-001NYSTATIN AND TRIAMCINOLONE ACETONIDE100,000 UNITS/GM;0.1%CREAM / TOPICALAT2017-08-14cb3db0bc1861…

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 UTC2026-02A208479-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208479-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208479-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208479-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208479-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208479-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208479-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208479-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208479-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208479-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208479-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208479-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208479-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208479-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208479-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208479-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208479-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208479-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208479-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208479-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208479-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A208479-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208479-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208479-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208479-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A208479-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208479-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208479-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208479-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208479-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208479-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208479-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208479-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208479-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208479-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208479-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208479-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208479-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208479-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208479-001AT1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN100000 [USP'U]/g
TRIAMCINOLONE ACETONIDE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BDF1O1C72EInternal UNII lookup
F446C597KAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1053753Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c82fc464-d021-4a7c-8141-46d3d80134a2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1433-2NYSTATIN AND TRIAMCINOLONE ACETONIDE15 g in 1 TUBECREAM15102
72162-1433-2NYSTATIN AND TRIAMCINOLONE ACETONIDE1 in 1 CARTONCREAM1102
72162-1433-3NYSTATIN AND TRIAMCINOLONE ACETONIDE30 g in 1 TUBECREAM30102
72162-1433-3NYSTATIN AND TRIAMCINOLONE ACETONIDE1 in 1 CARTONCREAM1102
72162-1433-6NYSTATIN AND TRIAMCINOLONE ACETONIDE1 in 1 CARTONCREAM1102
72162-1433-6NYSTATIN AND TRIAMCINOLONE ACETONIDE60 g in 1 TUBECREAM60102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1433-2GM - Gram72162-143339356e25-9144-4c24-9281-f0d5bd6d88a612024-04-05
72162-1433-3GM - Gram72162-14335fa63e0d-a4e1-4f87-9060-69462bf9a70d12025-06-13
72162-1433-6GM - Gram72162-1433af2b5ca1-061f-4a58-b26f-376b3b7e047a12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1433NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN, TRIAMCINOLONE ACETONIDE) CREAM [BRYANT RANCH PREPACK]102Current NDC, 6 package rows20250511_c82fc464-d021-4a7c-8141-46d3d80134a2.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepackf81f461b-54cd-45bf-bf96-da77a5edc1e62025-10-28Adverse reactionsExact identifier
application applno (ANDA): 208479
application number: ANDA208479
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepackc82fc464-d021-4a7c-8141-46d3d80134a22025-05-07Adverse reactionsExact identifier
application applno (ANDA): 208479
application number: ANDA208479
ndc (package): 72162-1433-2
ndc (product): 72162-1433
ndc11 (package): 72162143302
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.c8beaa42-eb3a-d160-e053-2a95a90a31082024-10-03Adverse reactionsExact identifier
application applno (ANDA): 208479
application number: ANDA208479
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepackb3056a63-d149-4ed4-84bc-918f5ff94a622024-08-22Adverse reactionsExact identifier
application applno (ANDA): 208479
application number: ANDA208479
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepack92b08b14-a933-454b-8b6f-4b5e7c6829532024-08-06Adverse reactionsExact identifier
application applno (ANDA): 208479
application number: ANDA208479
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepack6f25f129-a682-47d0-8788-bac21b65c8302024-03-29Adverse reactionsExact identifier
application applno (ANDA): 208479
application number: ANDA208479
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEPadagis Israel Pharmaceuticals Ltd92fc188d-4f3e-4d18-aaf1-c9e76b12b75b2023-03-01Adverse reactionsExact identifier
application applno (ANDA): 208479
application number: ANDA208479

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053753nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical CreamPSNc82fc464-d021-4a7c-8141-46d3d80134a2102
1053753nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSCDc82fc464-d021-4a7c-8141-46d3d80134a2102
1053753nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical CreamSYc82fc464-d021-4a7c-8141-46d3d80134a2102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1433-2721621433021 TUBE in 1 CARTON (72162-1433-2) / 15 g in 1 TUBE1 tube2024-03-11NoNoCurrent