Home NDC 71288-109 Cytarabine
Product NDC 71288-109
11-digit product format 712880109
Labeler code 71288
Product ID 71288-109_695b376b-3972-4aef-b003-f1fb6fcde5b7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cytarabine
Dosage form INJECTION, SOLUTION
Route INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA205696
Marketing category ANDA
Marketing start 2018-07-17
Substance CYTARABINE
Active strength 2 g/20mL
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 A205696-001 CYTARABINE CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205696-001 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 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205696-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP 2018-07-17 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYTARABINE 2 g/20mL
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 249364 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 71288-109-20 Cytarabine 1 in 1 CARTON INJECTION, SOLUTION 1 3 71288-109-20 Cytarabine 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-109 CYTARABINE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 3 Current NDC, Legacy NDC, 2 package rows 20240517_8105e590-fc7e-45b7-9604-c2d0d1be5eac.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 71288-109-20 71288010920 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-109-20) / 20 mL in 1 VIAL, SINGLE-DOSE 2018-07-17 0000-00-00 No No Current