Home NDC 49483-688-03 Paricalcitol
Product NDC 49483-688
Requested package NDC 49483-688-03
11-digit product format 494830688
Labeler code 49483
Product ID 49483-688_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 2015-12-30
Substance PARICALCITOL
Active strength 2 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.
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 2026-08-01 22:54:32 2026-06 A204948-001 PARICALCITOL 1MCG CAPSULE / ORAL AB 2016-10-07 a50c72e98297…2026-08-01 22:54:32 2026-06 A204948-002 PARICALCITOL 2MCG CAPSULE / ORAL AB 2016-10-07 a50c72e98297…2026-08-01 22:54:32 2026-06 A204948-003 PARICALCITOL 4MCG CAPSULE / ORAL AB 2016-10-07 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 · 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 49483-688-03 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 49483-688 PARICALCITOL CAPSULE, LIQUID FILLED [TIME CAP LABORATORIES, INC] 5 Current NDC, Legacy NDC, 1 package rows 20221203_f593b575-7537-4531-87fc-c1b0814fd018.zip
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 49483-688-03 49483068803 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-688-03) 2017-01-03 0000-00-00 No No Current