Home NDC 65162-824 Paricalcitol
Product NDC 65162-824
11-digit product format 651620824
Labeler code 65162
Product ID 65162-824_35e96bd0-ee09-4adc-a04d-7dcd43466786
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paricalcitol
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA204327
Marketing category ANDA
Marketing start 2016-01-15
Substance PARICALCITOL
Active strength 4 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 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 A204327-001 PARICALCITOL PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-01-13 A204327-002 PARICALCITOL PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-01-13 A204327-003 PARICALCITOL PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-01-13
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 · 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 A204327-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-01-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204327-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-01-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204327-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-01-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204327-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204327-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204327-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204327-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204327-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204327-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204327-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-01-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204327-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-01-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204327-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204327-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-01-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204327-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-01-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204327-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204327-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-01-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204327-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-01-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204327-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204327-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-01-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204327-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-01-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204327-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204327-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-01-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204327-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-01-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204327-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204327-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-01-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204327-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-01-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204327-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204327-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-01-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204327-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-01-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204327-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204327-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-01-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204327-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-01-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204327-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204327-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-01-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204327-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-01-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204327-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204327-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-01-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204327-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-01-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204327-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204327-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-01-13 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 65162-824-03 Paricalcitol 30 in 1 BOTTLE CAPSULE 30 13 65162-824-09 Paricalcitol 90 in 1 BOTTLE CAPSULE 90 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-824 PARICALCITOL CAPSULE [AMNEAL PHARMACEUTICALS LLC] 13 Current NDC, Legacy NDC, 2 package rows 20241031_cd937aab-6ed2-44ef-b91e-82738997ed10.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 Marketing end Sample Exclude flag Status 65162-824-03 65162082403 30 CAPSULE in 1 BOTTLE (65162-824-03) 30 capsule 2016-01-15 0000-00-00 No No Current 65162-824-09 65162082409 90 CAPSULE in 1 BOTTLE (65162-824-09) 90 capsule 2016-01-15 0000-00-00 No No Current