Paclitaxel 100mg per vial

Product NDC: 76282-768
Requested package NDC: 76282-768-09
11-digit product format: 762820768
Labeler code: 76282
Product ID: 76282-768_94c07774-2008-4ba9-bc92-1c723dcc5b25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paclitaxel protein-bound particles
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route: INTRAVENOUS
Labeler: EXELAN PHARMACEUTICALS INC.
Application: ANDA209657
Marketing category: ANDA
Marketing start: 2026-08-11
Substance: PACLITAXEL
Active strength: 100 mg/20mL
Pharmacologic classes: Microtubule Inhibition [PE], Microtubule 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
A209657-001	PACLITAXEL	PACLITAXEL	100MG/VIAL	POWDER / INTRAVENOUS	AB		2025-04-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209657-001	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
2026-10-15 13:18:30	2026-09	A209657-001	PACLITAXEL	100MG/VIAL	POWDER / INTRAVENOUS	AB	2025-04-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209657-001	PACLITAXEL	100MG/VIAL	POWDER / INTRAVENOUS	AB	2025-04-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209657-001	PACLITAXEL	100MG/VIAL	POWDER / INTRAVENOUS	AB	2025-04-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209657-001	PACLITAXEL	100MG/VIAL	POWDER / INTRAVENOUS	AB	2025-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209657-001	PACLITAXEL	100MG/VIAL	POWDER / INTRAVENOUS	AB	2025-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209657-001	PACLITAXEL	100MG/VIAL	POWDER / INTRAVENOUS	AB	2025-04-10	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209657-001	PACLITAXEL	100MG/VIAL	POWDER / INTRAVENOUS	AB	2025-04-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A209657-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209657-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209657-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209657-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209657-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209657-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209657-001	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 100mg per vial
Listing expiration: 2027-12-31

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
135502ff-002c-4a29-ba93-60855cf44f31	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paclitaxel 100mg per vial	PACLITAXEL PROTEIN-BOUND PARTICLES	EXELAN PHARMACEUTICALS INC.	135502ff-002c-4a29-ba93-60855cf44f31	2026-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209657 application number: ANDA209657 ndc (package): 76282-768-09 ndc (product): 76282-768 ndc11 (package): 76282076809
Paclitaxel protein-bound particles	PACLITAXEL PROTEIN-BOUND PARTICLES	Cipla USA Inc.	15eba86c-d9de-42e6-bc95-70ba4c015e72	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209657 application number: ANDA209657

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
76282-768-09	76282076809	1 VIAL, SINGLE-DOSE in 1 CARTON (76282-768-09) / 20 mL in 1 VIAL, SINGLE-DOSE	2026-08-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Paclitaxel 100mg per vial	EXELAN PHARMACEUTICALS INC. \| CIPLA LIMITED GOA	2026-08-10	HUMAN PRESCRIPTION DRUG LABEL	1