Home NDC 55150-212 PARICALCITOL
Product NDC 55150-212
11-digit product format 551500212
Labeler code 55150
Product ID 55150-212_9ecb6fd2-c8d0-4092-b53c-b63e8a835fba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PARICALCITOL
Dosage form INJECTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA205982
Marketing category ANDA
Marketing start 2018-10-09
Substance PARICALCITOL
Active strength 2 ug/mL
Pharmacologic classes Ergocalciferols [CS], Vitamin D Analog [EPC], 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205982-001 PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS 2018-10-09 A205982-002 PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS 2018-10-09 A205982-003 PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS 2018-10-09
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 4 · 126 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 A205982-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS 2018-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205982-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS 2018-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205982-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS 2018-10-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205982-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205982-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205982-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS 2018-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205982-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205982-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205982-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205982-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205982-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205982-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205982-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205982-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205982-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205982-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205982-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205982-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205982-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205982-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205982-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205982-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205982-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205982-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205982-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205982-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205982-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205982-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205982-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205982-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205982-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205982-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205982-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205982-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205982-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205982-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205982-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205982-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205982-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205982-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2018-10-09 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 117 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PARICALCITOL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PARICALCITOL 2 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6702D36OG5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200321 Internal RxNorm lookup 1736919 Internal RxNorm lookup 1736931 Internal RxNorm lookup 1807896 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 55150-212-01 PARICALCITOL 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 8 55150-212-01 PARICALCITOL 25 in 1 CARTON INJECTION 25 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-212 PARICALCITOL INJECTION [EUGIA US LLC] 7 Current NDC, Legacy NDC, 2 package rows 20231125_6937c596-9ca4-480e-9090-b9d8a3c271c8.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 Marketing start Marketing end Sample Exclude flag Status 55150-212-01 55150021201 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-212-01) / 1 mL in 1 VIAL, SINGLE-DOSE 2018-10-09 0000-00-00 No No Current