Paclitaxel protein-bound particles for injectable suspension (albumin-bound)

Product NDC: 68001-651
Requested package NDC: 68001-651-37
11-digit product format: 680010651
Labeler code: 68001
Product ID: 68001-651_3c3af5f5-c5d8-a6a1-e063-6294a90a68e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paclitaxel
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route: INTRAVENOUS
Labeler: BluePoint Laboratories
Application: ANDA216355
Marketing category: ANDA
Marketing start: 2025-07-18
Substance: PACLITAXEL
Active strength: 100 mg/20mL
Pharmacologic classes: Microtubule Inhibition [PE], Microtubule 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 43.

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
A216355-001	PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER / INTRAVENOUS	AB		2025-05-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A216355-001	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216355-001	PACLITAXEL	100MG/VIAL	POWDER / INTRAVENOUS	AB	2025-05-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216355-001	PACLITAXEL	100MG/VIAL	POWDER / INTRAVENOUS	AB	2025-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216355-001	PACLITAXEL	100MG/VIAL	POWDER / INTRAVENOUS	AB	2025-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216355-001	PACLITAXEL	100MG/VIAL	POWDER / INTRAVENOUS	AB	2025-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216355-001	PACLITAXEL	100MG/VIAL	POWDER / INTRAVENOUS	AB	2025-05-15	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216355-001	PACLITAXEL	100MG/VIAL	POWDER / INTRAVENOUS	AB	2025-05-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216355-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216355-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216355-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216355-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216355-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216355-001	AB	1	`a50c72e98297…`

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: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PACLITAXEL	100 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P88XT4IS4D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
583214	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
36d4a2ed-4b34-4b06-e063-6394a90acc86	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9bfd8626-d4ce-43ae-acb3-8de37f80302f	Product name	3	20260126
2cc1dc98-28db-3a82-b37e-4e50de7c4f94	Product name	5	20240102
a05831c4-07a7-44ad-9dc5-89391450ee82	Product name	1	20230323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68001-651-37	Paclitaxel protein-bound particles for injectable suspension (albumin-bound)	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		2
68001-651-37	Paclitaxel protein-bound particles for injectable suspension (albumin-bound)	20 mL in 1 VIAL, SINGLE-USE	INJECTION, POWDER, LYOPHILIZED,	20		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-651-37	EA - Each	68001-651	a2e69ea7-4022-4e42-921c-f4474183f279	1	2025-06-13

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paclitaxel	PACLITAXEL (AIBUMIN-BOUND)	Ningbo Shuangcheng Pharmaceutical Co., Ltd	4df3fda6-0b29-420e-ab91-81441ce914ed	2026-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216355 application number: ANDA216355
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)	PACLITAXEL	NorthStar Rx LLC	1e9d5093-fbfc-470a-8520-811c46a8870c	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216355 application number: ANDA216355
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)	PACLITAXEL	BluePoint Laboratories	36d4a2ed-4b34-4b06-e063-6394a90acc86	2025-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216355 application number: ANDA216355 ndc (package): 68001-651-37 ndc (product): 68001-651 ndc11 (package): 68001065137
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)	PACLITAXEL	Meitheal Pharmaceuticals Inc.	31e893aa-8d9e-4576-8614-eb2fe772bde4	2025-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216355 application number: ANDA216355

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P88XT4IS4D	PACLITAXEL	33069-62-4	PACLITAXEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
583214	PACLitaxel 100 MG Injection	PSN	36d4a2ed-4b34-4b06-e063-6394a90acc86	2
583214	paclitaxel 100 MG Injection	SCD	36d4a2ed-4b34-4b06-e063-6394a90acc86	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68001-651-37	68001065137	1 VIAL, SINGLE-USE in 1 CARTON (68001-651-37) / 20 mL in 1 VIAL, SINGLE-USE	2025-07-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)	BluePoint Laboratories \| Ningbo Shuangcheng Pharmaceutical Co., Ltd.	2025-08-13	HUMAN PRESCRIPTION DRUG LABEL	2