BSP 0820

Product NDC
69263-805
11-digit product format
692630805
Labeler code
69263
Product ID
69263-805_cd3d87dd-81c4-9299-e053-2995a90a47f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Sodium Phosphate, Betamethasone Acetate
Dosage form
KIT
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR
Labeler
Oaklock, LLC
Application
ANDA090747
Marketing category
ANDA
Marketing start
2020-07-13
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69263-805DDiscontinued by firm2026-08-11
excluded packagepackage69263-80569263-805-01DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69263-805-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69263-805-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69263-805-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69263-805-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69263-805-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69263-805-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69263-805-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69263-805-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69263-805-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69263-805-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69263-805-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69263-805-01557ba5c1ecfa…9c80585c8c6e…

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
A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATEBETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090747-001AB

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 UTC2026-02A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090747-001BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONAB2009-07-31cb3db0bc1861…

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 UTC2026-02A090747-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090747-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090747-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090747-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090747-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090747-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090747-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090747-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090747-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090747-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090747-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090747-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090747-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090747-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090747-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090747-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090747-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090747-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090747-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090747-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090747-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090747-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090747-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090747-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090747-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090747-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090747-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090747-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090747-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090747-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090747-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090747-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090747-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090747-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090747-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090747-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090747-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090747-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090747-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090747-001AB1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69263-805-012023-10-26C16284748780-1f386c64a-3648-0266-e053-dadaa90a7c1aBSP 0820 Rx only
69263-805-012023-01-30C16284748780-1f386c64a-3648-0266-e053-dadaa90a7c1aBSP 0820 Rx only

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betamethasone Sodium Phosphate and Betamethasone AcetateBETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATEAmerican Regent, Inc.335f17e7-069d-456c-8507-26253692f2ee2025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090747
application number: ANDA090747
Betamethasone Sodium Phosphate and Betamethasone AcetateBETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATEAmerican Regent, Inc.be3e57df-339a-4b7c-9528-d478af8c78552025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090747
application number: ANDA090747
Betamethasone Sodium Phosphate and Betamethasone AcetateBETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATEAmerican Regent, Inc.a363b861-4873-465e-8009-0e96906662242024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090747
application number: ANDA090747
Betamethasone Sodium Phosphate and Betamethasone AcetateBETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATEAsclemed USA, Inc.c0a09d83-2405-450b-9f35-803d128232132022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090747
application number: ANDA090747

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69263-805-01692630805011 KIT in 1 CARTON (69263-805-01) * 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0720-01) > 5 mL in 1 VIAL, MULTI-DOSE1 kit2020-07-130000-00-00NoNoCurrent