Home NDC 61703-303 CYTARABINE
Product NDC 61703-303
11-digit product format 617030303
Labeler code 61703
Product ID 61703-303_304df26a-131c-4ce1-999a-f13ade44373e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CYTARABINE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA072168
Marketing category ANDA
Marketing start 1990-08-31
Substance CYTARABINE
Active strength 20 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 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 A072168-001 CYTARABINE CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072168-001 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 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072168-001 CYTARABINE 20MG/ML INJECTABLE / INJECTION AP RS 1990-08-31 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 20 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 61703-303-46 CYTARABINE 50 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, SOLUTION 50 21 61703-303-46 CYTARABINE 1 in 1 CARTON INJECTION, SOLUTION 1 21
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.] 12 CYTARABINE ACTIVE MOIETY 04079A1RDZ CYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] 12 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB CYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] 12 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] 12 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] 12 WATER INACTIVE INGREDIENT 059QF0KO0R CYTARABINE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61703-303 CYTARABINE INJECTION, SOLUTION [HOSPIRA, INC.] 21 Current NDC, Legacy NDC, 2 package rows 20250119_681b5dc4-4fcf-4fab-ad78-02cb9a4a5dd0.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 61703-303-46 61703030346 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (61703-303-46) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE 1990-08-31 0000-00-00 No No Current