Home NDC 63323-120 Cytarabine
Product NDC 63323-120
11-digit product format 633230120
Labeler code 63323
Product ID 63323-120_648872de-503c-4140-9c0f-94f772177ac3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CYTARABINE
Dosage form INJECTION, SOLUTION
Route INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA076512
Marketing category ANDA
Marketing start 2004-11-29
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A076512-001 CYTARABINE CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076512-001 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 · 44 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 2026-10-15 13:18:30 2026-09 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076512-001 CYTARABINE 100MG/ML INJECTABLE / INJECTION AP RS 2004-01-15 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 Cytarabine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYTARABINE 100 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-120-20 Cytarabine 1 in 1 CARTON INJECTION, SOLUTION 1 5 63323-120-20 Cytarabine 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CYTARABINE ACTIVE INGREDIENT 04079A1RDZ CYTARABINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 CYTARABINE ACTIVE MOIETY 04079A1RDZ CYTARABINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB CYTARABINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CYTARABINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-120 CYTARABINE (CYTARABINE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 5 Current NDC, Legacy NDC, 2 package rows 20210710_c4fdc56e-efd7-4825-a518-ef430b2b3df0.zip
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 63323-120-20 63323012020 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-120-20) / 20 mL in 1 VIAL, SINGLE-DOSE 2004-11-29 0000-00-00 No No Current