Zilretta

Product NDC
65250-003
Requested package NDC
65250-003-01
11-digit product format
652500003
Labeler code
65250
Product ID
65250-003_9806c4e8-2b5d-4e6b-915b-60426d912fb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide extended-release injectable suspension
Dosage form
KIT
Route
INTRA-ARTICULAR
Labeler
Pacira Pharmaceuticals, Inc.
Application
NDA208845
Marketing category
NDA
Marketing start
2017-10-06
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N208845-001ZILRETTATRIAMCINOLONE ACETONIDE32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208845-00188284402031-08-04Drug product2017-10-31
N208845-00195550482031-08-04U-21512017-10-31

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-0684e616aacf4f…
2026-08-18 06:07:402026-07N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-0687673890dc5c…
2021-03-12 10:30 UTC2021-03N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-063f01610625f2…
2019-09-15 20:21 UTC2019-09N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06b00525d2431f…
2019-07-19 19:46 UTC2019-07N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-063f0d92c62455…
2023-05-13 08:27 UTC2023-05N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06053a50430f4f…
2023-01-26 05:58 UTC2023-01N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208845-001ZILRETTA32MG/VIALFOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULARRLD, RS2017-10-06f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N208845-00188284402031-08-04Drug product2017-10-3184e616aacf4f…
2026-09-14 22:38:342026-08N208845-00195550482031-08-04U-21512017-10-3184e616aacf4f…
2026-08-18 06:07:402026-07N208845-00188284402031-08-04Drug product2017-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07N208845-00195550482031-08-04U-21512017-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208845-00188284402031-08-04Drug product2017-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208845-00195550482031-08-04U-21512017-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208845-00188284402031-08-04Drug product2017-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208845-00195550482031-08-04U-21512017-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N208845-00188284402031-08-04Drug product2017-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208845-00195550482031-08-04U-21512017-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208845-00188284402031-08-04Drug product2017-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208845-00195550482031-08-04U-21512017-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208845-00188284402031-08-04Drug product2017-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208845-00195550482031-08-04U-21512017-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208845-00188284402031-08-04Drug product2017-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208845-00195550482031-08-04U-21512017-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208845-00188284402031-08-04Drug product2017-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208845-00195550482031-08-04U-21512017-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208845-00188284402031-08-04Drug product2017-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208845-00195550482031-08-04U-21512017-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208845-00188284402031-08-04Drug product2017-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208845-00195550482031-08-04U-21512017-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208845-00188284402031-08-04Drug product2017-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N208845-00195550482031-08-04U-21512017-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208845-00188284402031-08-04Drug product2017-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208845-00195550482031-08-04U-21512017-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208845-00188284402031-08-04Drug product2017-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208845-00195550482031-08-04U-21512017-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208845-00188284402031-08-04Drug product2017-10-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208845-00195550482031-08-04U-21512017-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208845-00188284402031-08-04Drug product2017-10-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05N208845-00195550482031-08-04U-21512017-10-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208845-00188284402031-08-04Drug product2017-10-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208845-00195550482031-08-04U-21512017-10-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208845-00188284402031-08-04Drug product2017-10-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N208845-00195550482031-08-04U-21512017-10-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208845-00188284402031-08-04Drug product2017-10-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N208845-00195550482031-08-04U-21512017-10-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208845-00188284402031-08-04Drug product2017-10-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N208845-00195550482031-08-04U-21512017-10-3174a2ff9319b5…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N208845-001NP2020-10-0674a2ff9319b5…
2020-12-22 03:56 UTC2020-12N208845-001NP2020-10-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208845-001NP2020-10-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208845-001NP2020-10-063f01610625f2…
2019-09-15 20:21 UTC2019-09N208845-001NP2020-10-06b00525d2431f…
2019-07-19 19:46 UTC2019-07N208845-001NP2020-10-06ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Zilretta
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1947131Internal RxNorm lookup
1947133Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cd5c4673-21f2-4126-9556-da847b3a228bAvailable 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
65250-001-01Zilretta1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SUSPENSIO132 mg6
65250-003-01Zilretta1 in 1 CARTONKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65250-003-01EA - Each65250-00339d91b54-3f2c-472e-bff3-5649171d000712023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65250-003ZILRETTA (TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION) KIT [PACIRA PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20250112_cd5c4673-21f2-4126-9556-da847b3a228b.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZilrettaTRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSIONPacira Pharmaceuticals, Inc.cd5c4673-21f2-4126-9556-da847b3a228b2026-06-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 208845
application number: NDA208845
ndc (package): 65250-003-01
ndc (product): 65250-003
ndc11 (package): 65250000301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1947131triamcinolone acetonide 32 MG Extended-Release InjectionPSNcd5c4673-21f2-4126-9556-da847b3a228b6
1947133Zilretta 32 MG Extended-Release InjectionPSNcd5c4673-21f2-4126-9556-da847b3a228b6
1947133triamcinolone acetonide 32 MG Injection [Zilretta]SBDcd5c4673-21f2-4126-9556-da847b3a228b6
1947131triamcinolone acetonide 32 MG InjectionSCDcd5c4673-21f2-4126-9556-da847b3a228b6
1947133Zilretta 32 MG InjectionSYcd5c4673-21f2-4126-9556-da847b3a228b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65250-003-01652500003011 KIT in 1 CARTON (65250-003-01) * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (65250-001-01) * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE (65250-002-01) 1 kit2017-10-060000-00-00NoNoCurrent