Home NDC 61703-319 Cytarabine
Product NDC 61703-319
11-digit product format 617030319
Labeler code 61703
Product ID 61703-319_2af445e4-993f-4fec-a276-c01ff2451e92
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CYTARABINE
Dosage form INJECTION, SOLUTION
Route INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
Labeler Hospira, Inc.
Application ANDA075383
Marketing category ANDA
Marketing start 1999-11-22
Substance CYTARABINE
Active strength 100 mg/mL
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61703-319-22 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61703-319-22 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61703-319-22 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61703-319-22 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61703-319-22 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61703-319-22 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61703-319-22 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61703-319-22 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61703-319-22 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 61703-319-22 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 61703-319-22 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 61703-319-22 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A075383-001 CYTARABINE CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075383-001 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 · 42 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 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075383-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 1999-11-22 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cytarabine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYTARABINE 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04079A1RDZ Internal UNII 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 61703-319-22 Cytarabine 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 13 61703-319-22 Cytarabine 1 in 1 CARTON INJECTION, SOLUTION 1 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CYTARABINE ACTIVE INGREDIENT 04079A1RDZ CYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] 1 CYTARABINE ACTIVE MOIETY 04079A1RDZ CYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB CYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61703-319 CYTARABINE INJECTION, SOLUTION [HOSPIRA, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20220827_277597b0-7d85-40a3-a34a-70c6a883fc6d.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 · 2 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 61703-319-22 61703031922 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-319-22) / 20 mL in 1 VIAL, SINGLE-DOSE 1999-11-22 0000-00-00 No No Current