Home NDC 16729-310 Paricalcitol
Product NDC 16729-310
11-digit product format 167290310
Labeler code 16729
Product ID 16729-310_1e7e9c4e-79dd-a776-e063-6394a90a43a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paricalcitol
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Accord Healthcare, Inc.
Application NDA207174
Marketing category NDA
Marketing start 2016-03-24
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 N207174-001 PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 N207174-002 PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 N207174-003 PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04
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 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207174-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207174-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207174-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2016-02-04 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 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200321 Internal RxNorm lookup 1736919 Internal RxNorm lookup 1736931 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 16729-310-08 Paricalcitol 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 5 16729-310-08 Paricalcitol 25 in 1 CARTON INJECTION, SOLUTION 25 5 16729-310-63 Paricalcitol 1 in 1 CARTON INJECTION, SOLUTION 1 5 16729-310-63 Paricalcitol 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-310 PARICALCITOL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.] 5 Current NDC, Legacy NDC, 4 package rows 20240806_2b7c7587-2042-0d9c-e054-00144ff88e88.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 16729-310-08 16729031008 25 VIAL, SINGLE-DOSE in 1 CARTON (16729-310-08) / 1 mL in 1 VIAL, SINGLE-DOSE 2016-03-24 0000-00-00 No No Current 16729-310-63 16729031063 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-310-63) / 1 mL in 1 VIAL, SINGLE-DOSE 2016-03-24 0000-00-00 No No Current