Home NDC 70518-4642 Doxercalciferol
Product NDC 70518-4642
11-digit product format 705184642
Labeler code 70518
Product ID 70518-4642_5087b0ee-cda2-1722-e063-6294a90a36cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxercalciferol
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA205360
Marketing category ANDA
Marketing start 2026-04-28
Substance DOXERCALCIFEROL
Active strength .5 ug/1
Pharmacologic classes Ergocalciferols [CS], Vitamin D2 Analog [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205360-001 DOXERCALCIFEROL DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL AB 2020-09-15 A205360-002 DOXERCALCIFEROL DOXERCALCIFEROL 1MCG CAPSULE / ORAL AB 2020-09-15 A205360-003 DOXERCALCIFEROL DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL AB RS 2020-09-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 3 · 111 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 A205360-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL AB 2020-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205360-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL AB 2020-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205360-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL AB RS 2020-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205360-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL AB 2020-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205360-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL AB 2020-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205360-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL AB RS 2020-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205360-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL AB 2020-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205360-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL AB 2020-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205360-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL AB 2020-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205360-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL AB 2020-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205360-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL AB 2020-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205360-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL AB 2020-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205360-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL AB 2020-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205360-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL AB 2020-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205360-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL AB 2020-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205360-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL AB 2020-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205360-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL AB 2020-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205360-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL AB 2020-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205360-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL AB 2020-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205360-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL AB 2020-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205360-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL AB 2020-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205360-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL AB 2020-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205360-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL AB 2020-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205360-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL AB 2020-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205360-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL AB 2020-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205360-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL AB 2020-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205360-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL AB 2020-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205360-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL AB 2020-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205360-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL AB 2020-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205360-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL AB 2020-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205360-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL AB 2020-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205360-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL AB 2020-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205360-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL AB 2020-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205360-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL AB 2020-09-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205360-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL AB 2020-09-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205360-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL AB 2020-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205360-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL AB 2020-09-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205360-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL AB 2020-09-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205360-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL AB 2020-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205360-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL AB 2020-09-15 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Doxercalciferol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXERCALCIFEROL .5 ug/1
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 406503 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 70518-4642-0 Doxercalciferol 50 in 1 BOX CAPSULE 50 1 70518-4642-1 Doxercalciferol 1 in 1 POUCH CAPSULE 1 1
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4642-0 70518464200 50 POUCH in 1 BOX (70518-4642-0) / 1 CAPSULE in 1 POUCH (70518-4642-1) 50 pouch 2026-04-28 No No Current 70518-4642-1 70518464201 1 in 1 POUCH Historical 70518-4642-2 70518464202 100 POUCH in 1 BOX (70518-4642-2) / 1 CAPSULE in 1 POUCH (70518-4642-1) 100 pouch 2026-07-17 0 Current