Cytarabine

Product NDC: 71288-168
11-digit product format: 712880168
Labeler code: 71288
Product ID: 71288-168_038a9b4b-a951-4c8c-be74-00a4a64eedd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cytarabine
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Meitheal Pharmaceuticals Inc.
Application: ANDA206190
Marketing category: ANDA
Marketing start: 2017-11-09
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 1.

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
A206190-001	CYTARABINE	CYTARABINE	20MG/ML	INJECTABLE / INJECTION			2017-11-09

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION	AP	2017-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION	AP	2017-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION	AP	2017-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION	AP	2017-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION	AP	2017-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION	AP	2017-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION	AP	2017-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION	AP	2017-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206190-001	CYTARABINE	20MG/ML	INJECTABLE / INJECTION		2017-11-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A206190-001	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206190-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206190-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206190-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206190-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206190-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206190-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206190-001	AP	1	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cytarabine
Listing expiration: 2026-12-31

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
240416	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1be2668b-d76f-4c65-aea9-86c5c40889a2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
04c28f2f-dbd2-41cf-afd8-2fe8b3fb2f93	Product name	2	20210115
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6b50ac01-634d-431e-b6ec-67435668b5b5	Product name	1	20200605
9a73eb90-b58c-4fa3-9acb-c965ada7a226	Product name	1	20200605
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
699672ea-953a-2798-2891-e277960c6893	Product name	2	20180914
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
675b5a39-d8c3-40a3-b593-72d314eef224	Product name	1	20170829
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
21b54d6a-c9b4-eec7-5d08-a7e2c08084eb	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71288-168-50	Cytarabine	50 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	50		3
71288-168-50	Cytarabine	1 in 1 CARTON	INJECTION, SOLUTION	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71288-168	CYTARABINE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 2 package rows	20220707_1be2668b-d76f-4c65-aea9-86c5c40889a2.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cytarabine	CYTARABINE	Meitheal Pharmaceuticals Inc.	1be2668b-d76f-4c65-aea9-86c5c40889a2	2022-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206190 application number: ANDA206190 ndc (product): 71288-168

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04079A1RDZ	CYTARABINE	147-94-4	CYTARABINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
240416	cytarabine 20 MG/ML Injectable Solution	PSN	1be2668b-d76f-4c65-aea9-86c5c40889a2	3
240416	cytarabine 20 MG/ML Injectable Solution	SCD	1be2668b-d76f-4c65-aea9-86c5c40889a2	3
240416	ara-C 20 MG/ML Injectable Solution	SY	1be2668b-d76f-4c65-aea9-86c5c40889a2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71288-168-50	71288016850	1 VIAL, MULTI-DOSE in 1 CARTON (71288-168-50) / 50 mL in 1 VIAL, MULTI-DOSE	2017-11-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cytarabine Injection (For Intravenous or Subcutaneous Use)	Meitheal Pharmaceuticals Inc. \| Kindos Pharmaceuticals Co., Ltd.	2022-07-06	HUMAN PRESCRIPTION DRUG LABEL	3