Home NDC 0409-0801-01 Nipent
Product NDC 0409-0801
Requested package NDC 0409-0801-01
11-digit product format 004090801
Labeler code 0409
Product ID 0409-0801_5db62458-cb13-4a2a-b7ee-6ed3fca88a8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PENTOSTATIN
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA020122
Marketing category NDA
Marketing start 2007-08-15
Substance PENTOSTATIN
Active strength 2 mg/mL
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020122-001 NIPENT PENTOSTATIN 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020122-001 AP
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 2 · 43 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 2026-09-14 22:38:34 2026-08 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020122-001 NIPENT 10MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1991-10-11 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Nipent
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PENTOSTATIN 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 395575MZO7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 105607 Internal RxNorm lookup 240573 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 0409-0801-01 Nipent 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 26 0409-0801-01 Nipent 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PENTOSTATIN ACTIVE INGREDIENT 395575MZO7 NIPENT (PENTOSTATIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 13 PENTOSTATIN ACTIVE MOIETY 395575MZO7 NIPENT (PENTOSTATIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 13 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB NIPENT (PENTOSTATIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 13 MANNITOL INACTIVE INGREDIENT 3OWL53L36A NIPENT (PENTOSTATIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 13 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I NIPENT (PENTOSTATIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-0801 NIPENT (PENTOSTATIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 25 Current NDC, Legacy NDC, 2 package rows 20240927_674e0e6d-46ed-4868-9196-04019d667716.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 0409-0801-01 00409080101 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0801-01) / 5 mL in 1 VIAL, SINGLE-DOSE 2007-08-15 0000-00-00 No No Current