Home NDC 62332-690 Doxercalciferol
Product NDC 62332-690
11-digit product format 623320690
Labeler code 62332
Product ID 62332-690_e253acbe-299e-4244-8c96-181d26feea3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxercalciferol
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Alembic Pharmaceuticals Inc.
Application ANDA215810
Marketing category ANDA
Marketing start 2023-06-15
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 A215810-001 DOXERCALCIFEROL DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215810-001 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 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215810-001 DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) INJECTABLE / INJECTION AP 2023-06-15 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Doxercalciferol
Listing expiration 2027-12-31 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 62332-690-02 Doxercalciferol 2 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 2 6 62332-690-30 Doxercalciferol 50 in 1 CARTON INJECTION, SOLUTION 50 6 62332-690-50 Doxercalciferol 25 in 1 CARTON INJECTION, SOLUTION 25 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-690 DOXERCALCIFEROL INJECTION, SOLUTION [ALEMBIC PHARMACEUTICALS INC.] 6 Current NDC, 3 package rows 20240711_7d07fa4f-f2a2-4c2b-86bf-c0a4691c1a0a.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 Sample Exclude flag Status 62332-690-02 62332069002 2 mL in 1 VIAL, MULTI-DOSE 2 ml Historical 62332-690-30 62332069030 50 VIAL, MULTI-DOSE in 1 CARTON (62332-690-30) / 2 mL in 1 VIAL, MULTI-DOSE (62332-690-02) 2023-06-15 No No Current 62332-690-50 62332069050 25 VIAL, MULTI-DOSE in 1 CARTON (62332-690-50) / 2 mL in 1 VIAL, MULTI-DOSE (62332-690-02) 2023-06-15 No No Current