Triamcinolone Acetonide

Product NDC
63629-8841
11-digit product format
636298841
Labeler code
63629
Product ID
63629-8841_9aa222aa-d4ce-4aba-9ebd-81405615d3fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA085691
Marketing category
ANDA
Marketing start
1978-02-14
Substance
TRIAMCINOLONE ACETONIDE
Active strength
.25 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085691-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 1982
A085691-002TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 1982
A085691-003TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A085691-001AT
A085691-002AT
A085691-003AT

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A085691-001TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085691-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085691-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085691-001TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085691-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085691-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A085691-001TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085691-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085691-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085691-001TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085691-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085691-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085691-001TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085691-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085691-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085691-001TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085691-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085691-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085691-001TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085691-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085691-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085691-001TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085691-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085691-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085691-001TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085691-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085691-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085691-001TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A085691-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A085691-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085691-001TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085691-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085691-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085691-001TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085691-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085691-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085691-001TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085691-002TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALATApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085691-003TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALATApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085691-001TRIAMCINOLONE ACETONIDE0.025%OINTMENT / TOPICALATApproved before 19828072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A085691-001AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085691-002AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085691-003AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085691-001AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085691-002AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085691-003AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085691-001AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085691-002AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085691-003AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085691-001AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085691-002AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085691-003AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085691-001AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085691-002AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085691-003AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085691-001AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085691-002AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085691-003AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085691-001AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085691-002AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085691-003AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085691-001AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085691-002AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085691-003AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085691-001AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085691-002AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085691-003AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085691-001AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10A085691-002AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10A085691-003AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085691-001AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085691-002AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085691-003AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085691-001AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085691-002AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085691-003AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085691-001AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085691-002AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085691-003AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085691-001AT18072bd15b7f6…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEAsclemed USA, Inc.b20c22b2-9a74-4b71-9015-40838fd2d1932026-03-10Adverse reactionsExact identifier
application applno (ANDA): 085691
application number: ANDA085691
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCa5cc640f-c72d-49fa-b970-906c9ffd86292026-01-28Adverse reactionsExact identifier
application applno (ANDA): 085691
application number: ANDA085691
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepackee274346-938b-4678-9146-486ca65bcba52024-01-15Adverse reactionsExact identifier
application applno (ANDA): 085691
application number: ANDA085691
ndc (product): 63629-8841

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE.25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1085633Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ee274346-938b-4678-9146-486ca65bcba5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
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
63629-8841-1Triamcinolone Acetonide80 g in 1 TUBEOINTMENT80102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8841-1GM - Gram63629-8841bf6c02c4-4425-4842-94d5-62d54a3046e712021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8841TRIAMCINOLONE ACETONIDE OINTMENT [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240116_ee274346-938b-4678-9146-486ca65bcba5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085633triamcinolone acetonide 0.025 % Topical OintmentPSNee274346-938b-4678-9146-486ca65bcba5102
1085633triamcinolone acetonide 0.00025 MG/MG Topical OintmentSCDee274346-938b-4678-9146-486ca65bcba5102
1085633triamcinolone acetonide 0.025 % Topical OintmentSYee274346-938b-4678-9146-486ca65bcba5102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8841-16362988410180 g in 1 TUBE (63629-8841-1) 80 g2021-09-100000-00-00NoNoCurrent