Home NDC 63629-2453 Paricalcitol
Product NDC 63629-2453
11-digit product format 636292453
Labeler code 63629
Product ID 63629-2453_d80ae603-ed3e-4687-a16f-11112827e96c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paricalcitol
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA202539
Marketing category ANDA
Marketing start 2016-08-16
Substance PARICALCITOL
Active strength 2 ug/1
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 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 A202539-001 PARICALCITOL PARICALCITOL 1MCG CAPSULE / ORAL AB 2014-03-27 A202539-002 PARICALCITOL PARICALCITOL 2MCG CAPSULE / ORAL AB 2014-03-27 A202539-003 PARICALCITOL PARICALCITOL 4MCG CAPSULE / ORAL AB 2014-03-27
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 A202539-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2014-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202539-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2014-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202539-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2014-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202539-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2014-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202539-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2014-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202539-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2014-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202539-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2014-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202539-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2014-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202539-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2014-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202539-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2014-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202539-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2014-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202539-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2014-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202539-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2014-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202539-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2014-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202539-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2014-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202539-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2014-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202539-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2014-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202539-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2014-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202539-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2014-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202539-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2014-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202539-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2014-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202539-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2014-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202539-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2014-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202539-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2014-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202539-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2014-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202539-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2014-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202539-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2014-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202539-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2014-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202539-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2014-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202539-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2014-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202539-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2014-03-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202539-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2014-03-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202539-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2014-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202539-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2014-03-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202539-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2014-03-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202539-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2014-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202539-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2014-03-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202539-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2014-03-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202539-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2014-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202539-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2014-03-27 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 2 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 577317 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 63629-2453-1 Paricalcitol 30 in 1 BOTTLE, PLASTIC CAPSULE 30 106
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2453 PARICALCITOL CAPSULE [BRYANT RANCH PREPACK] 106 Current NDC, Legacy NDC, 1 package rows 20240921_52ca3d88-e85d-44a9-8aa7-eb25a8a73f6f.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 · 5 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 63629-2453-1 63629245301 30 CAPSULE in 1 BOTTLE, PLASTIC (63629-2453-1) 30 capsule 2021-03-08 0000-00-00 No No Current