FLUDARABINE PHOSPHATE

Product NDC: 16729-131
Requested package NDC: 16729-131-30
11-digit product format: 167290131
Labeler code: 16729
Product ID: 16729-131_ee323333-c885-25d1-e053-2995a90acddc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FLUDARABINE
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Accord Healthcare, Inc.
Marketing category: UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start: 2022-11-22
Marketing end: 0000-00-00
Substance: FLUDARABINE PHOSPHATE
Active strength: 25 mg/mL
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16729-131	16729-131-30	D	Discontinued by firm		2026-08-11

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 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-131-30	ML - Milliliter	16729-131	bc53f60a-5a4a-4723-9316-5e8f59c4e619	1	2022-12-07

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1X9VK9O1SC	FLUDARABINE PHOSPHATE	75607-67-9	FLUDARABINE PHOSPHATE
P2K93U8740	FLUDARABINE	21679-14-1	FLUDARABINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-131-30	16729013130	1 VIAL, SINGLE-DOSE in 1 CARTON (16729-131-30) > 2 mL in 1 VIAL, SINGLE-DOSE	2022-11-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fludarabine Phosphate Injection, USP	Accord Healthcare, Inc. \| Intas Pharmaceuticals Limited	2022-11-24	HUMAN PRESCRIPTION DRUG LABEL	2

FLUDARABINE PHOSPHATE

NDC auxiliary status#

Observed NDC auxiliary status history#

DailyMed Billing Units#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#