Beta 1 Kit

Product NDC
69263-822
11-digit product format
692630822
Labeler code
69263
Product ID
69263-822_cd3d6948-6526-a7ec-e053-2995a90ae27d
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
2015-08-25
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 productproduct69263-822DDiscontinued by firm2026-08-11
excluded packagepackage69263-82269263-822-01DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct69263-822DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69263-82269263-822-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69263-822-012023-12-12C16284748780-1f386c64a-3007-0266-e053-dadaa90a7c1aBeta 1 Kit Rx only
69263-822-012023-01-30C16284748780-1f386c64a-3007-0266-e053-dadaa90a7c1aBeta 1 Kit Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69263-822-01EA - Each69263-82226f4760a-6d5e-4804-8c81-a4f204f958c912015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69263-822BETA 1 KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE) KIT [OAKLOCK, LLC]9Legacy NDC20241019_7e63c73d-30b2-4f47-a817-0313a08281c1.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 · 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
69263-822-01692630822011 KIT in 1 CARTON (69263-822-01) * 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0720-01) > 5 mL in 1 VIAL, MULTI-DOSE1 kit2015-08-250000-00-00NoNoCurrent