Home NDC 55150-358 Doxercalciferol
Product NDC 55150-358
11-digit product format 551500358
Labeler code 55150
Product ID 55150-358_211361e9-87ad-476a-af8f-8b887c3b6c4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxercalciferol
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA213717
Marketing category ANDA
Marketing start 2022-01-24
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213717-001 DOXERCALCIFEROL DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION 2022-01-24 A213717-002 DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION 2022-01-24
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 · 66 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 2026-08-18 06:07:40 2026-07 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION 2022-01-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION 2022-01-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION 2022-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213717-001 DOXERCALCIFEROL 2MCG/ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213717-002 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2022-01-24 6a51e52b5d6a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 61 observed states.
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 282609 Internal RxNorm lookup 1790208 Internal RxNorm lookup 1790219 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 55150-358-01 Doxercalciferol 1 in 1 CARTON INJECTION, SOLUTION 1 3 55150-358-01 Doxercalciferol 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 3 55150-358-50 Doxercalciferol 50 in 1 CARTON INJECTION, SOLUTION 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-358 DOXERCALCIFEROL INJECTION, SOLUTION [EUGIA US LLC] 2 Current NDC, Legacy NDC, 3 package rows 20240222_3376536b-043d-478a-b129-7ce11ec94e3e.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.
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 55150-358-01 55150035801 1 in 1 CARTON Historical 55150-358-50 55150035850 50 CARTON in 1 CARTON (55150-358-50) / 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-358-01) / 2 mL in 1 VIAL, SINGLE-DOSE 50 carton 2022-01-24 0000-00-00 No No Current