Home NDC 70121-1035 Paricalcitol
Product NDC 70121-1035
11-digit product format 701211035
Labeler code 70121
Product ID 70121-1035_26de8aad-c6ec-4bac-ae94-5772a69b79ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paricalcitol
Dosage form INJECTION
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals LLC
Application ANDA206699
Marketing category ANDA
Marketing start 2017-03-09
Substance PARICALCITOL
Active strength 10 ug/2mL
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 A206699-001 PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 A206699-002 PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 A206699-003 PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09
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 A206699-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206699-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206699-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206699-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206699-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206699-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206699-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206699-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206699-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206699-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206699-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206699-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206699-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206699-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206699-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206699-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206699-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206699-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206699-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206699-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206699-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206699-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206699-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206699-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206699-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206699-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206699-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206699-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206699-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206699-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206699-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206699-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206699-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206699-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206699-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206699-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206699-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206699-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206699-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206699-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2017-03-09 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 10 ug/2mL
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200321 Internal RxNorm lookup 1736919 Internal RxNorm lookup 1736931 Internal RxNorm lookup 1807896 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 70121-1035-1 Paricalcitol 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 12 70121-1035-5 Paricalcitol 25 in 1 CARTON INJECTION 25 12 70121-1035-7 Paricalcitol 10 in 1 CARTON INJECTION 10 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70121-1035 PARICALCITOL INJECTION [AMNEAL PHARMACEUTICALS LLC] 12 Current NDC, Legacy NDC, 3 package rows 20241224_8e0b016c-4bda-487e-b525-63abfb772761.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 70121-1035-1 70121103501 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 70121-1035-5 70121103505 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1035-5) / 2 mL in 1 VIAL, SINGLE-DOSE (70121-1035-1) 2017-03-09 0000-00-00 No No Current 70121-1035-7 70121103507 10 VIAL, SINGLE-DOSE in 1 CARTON (70121-1035-7) / 2 mL in 1 VIAL, SINGLE-DOSE (70121-1035-1) 2017-03-09 0000-00-00 No No Current