Home NDC 43598-850 DOXERCALCIFEROL
Product NDC 43598-850
11-digit product format 435980850
Labeler code 43598
Product ID 43598-850_7eef9f4d-4266-ea15-9f02-978034760eb7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXERCALCIFEROL
Dosage form INJECTION
Route INTRAVENOUS
Labeler Dr.Reddy's Laboratories Inc
Application ANDA210452
Marketing category ANDA
Marketing start 2019-11-13
Substance DOXERCALCIFEROL
Active strength 4 ug/2mL
Pharmacologic classes Ergocalciferols [CS], Vitamin D2 Analog [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 A210452-001 DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210452-001 AP
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.
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 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210452-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2019-09-26 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base DOXERCALCIFEROL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXERCALCIFEROL 4 ug/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3DIZ9LF5Y9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 282609 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 43598-850-11 DOXERCALCIFEROL 2 mL in 1 VIAL, MULTI-DOSE INJECTION 2 4 43598-850-50 DOXERCALCIFEROL 50 in 1 CARTON INJECTION 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-850 DOXERCALCIFEROL INJECTION [DR.REDDY'S LABORATORIES INC] 4 Current NDC, Legacy NDC, 2 package rows 20241222_f472b60a-e6f5-1a87-3eff-539d6287d285.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43598-850-11 43598085011 2 mL in 1 VIAL, MULTI-DOSE 2 ml Historical 43598-850-50 43598085050 50 VIAL, MULTI-DOSE in 1 CARTON (43598-850-50) / 2 mL in 1 VIAL, MULTI-DOSE (43598-850-11) 2019-11-13 0000-00-00 No No Current