Home NDC 49483-689 Paricalcitol
Product NDC 49483-689
11-digit product format 494830689
Labeler code 49483
Product ID 49483-689_eed565d0-059d-eef6-e053-2a95a90ac962
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paricalcitol
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler TIME CAP LABORATORIES, INC
Application ANDA204948
Marketing category ANDA
Marketing start 2017-01-03
Substance PARICALCITOL
Active strength 4 ug/1
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204948-001 PARICALCITOL PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 A204948-002 PARICALCITOL PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-10-07 A204948-003 PARICALCITOL PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-10-07
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 4 · 123 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 A204948-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204948-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204948-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204948-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204948-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204948-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204948-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204948-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204948-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204948-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204948-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204948-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204948-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204948-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204948-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204948-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204948-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204948-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204948-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204948-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204948-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204948-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204948-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-10-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204948-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-10-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204948-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204948-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-10-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204948-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204948-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204948-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-10-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204948-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-10-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204948-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204948-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-10-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204948-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-10-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204948-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204948-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-10-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204948-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-10-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204948-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204948-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-10-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204948-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-10-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204948-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 4 ug/1
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 577315 Internal RxNorm lookup 577317 Internal RxNorm lookup 577324 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 49483-689-03 Paricalcitol 30 in 1 BOTTLE CAPSULE, LIQUID FILLED 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-689 PARICALCITOL CAPSULE, LIQUID FILLED [TIME CAP LABORATORIES, INC] 5 Current NDC, Legacy NDC, 1 package rows 20221203_f593b575-7537-4531-87fc-c1b0814fd018.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 Marketing start Marketing end Sample Exclude flag Status 49483-689-03 49483068903 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-689-03) 2017-01-03 0000-00-00 No No Current