Home NDC 0517-0799 Betamethasone Sodium Phosphate and Betamethasone Acetate
Product NDC 0517-0799
11-digit product format 005170799
Labeler code 0517
Product ID 0517-0799_94369498-af74-44d3-a7f2-0f138d140d48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Betamethasone Sodium Phosphate and Betamethasone Acetate
Dosage form INJECTION, SUSPENSION
Route INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR
Labeler American Regent, Inc.
Application ANDA090747
Marketing category ANDA
Marketing start 2019-11-01
Substance BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
Active strength 3; 3 mg/mL; mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090747-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090747-001 BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE 3MG/ML;EQ 3MG BASE/ML INJECTABLE / INJECTION AB 2009-07-31 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Betamethasone Sodium Phosphate and Betamethasone Acetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BETAMETHASONE ACETATE 3 mg/mL BETAMETHASONE SODIUM PHOSPHATE 3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TI05AO53L7 Internal UNII lookup 7BK02SCL3W Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 578803 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0517-0799-01 Betamethasone Sodium Phosphate and Betamethasone Acetate 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SUSPENSION 5 4 0517-0799-01 Betamethasone Sodium Phosphate and Betamethasone Acetate 1 in 1 CARTON INJECTION, SUSPENSION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0517-0799 BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE INJECTION, SUSPENSION [AMERICAN REGENT, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20221203_be3e57df-339a-4b7c-9528-d478af8c7855.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Betamethasone Sodium Phosphate and Betamethasone Acetate BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE American Regent, Inc. 335f17e7-069d-456c-8507-26253692f2ee 2025-11-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090747 application number: ANDA090747 Betamethasone Sodium Phosphate and Betamethasone Acetate BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE American Regent, Inc. be3e57df-339a-4b7c-9528-d478af8c7855 2025-11-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090747 application number: ANDA090747 ndc (product): 0517-0799 Betamethasone Sodium Phosphate and Betamethasone Acetate BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE American Regent, Inc. a363b861-4873-465e-8009-0e9690666224 2024-09-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090747 application number: ANDA090747 Betamethasone Sodium Phosphate and Betamethasone Acetate BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE Asclemed USA, Inc. c0a09d83-2405-450b-9f35-803d12823213 2022-10-12 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090747 application number: ANDA090747
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0517-0799-01 00517079901 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0799-01) / 5 mL in 1 VIAL, MULTI-DOSE 2019-11-01 0000-00-00 No No Current