Fosaprepitant

Product NDC: 69539-181
11-digit product format: 695390181
Labeler code: 69539
Product ID: 69539-181_1639612b-41ec-4f2b-a514-967000c5214e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fosaprepitant
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: MSN LABORATORIES PRIVATE LIMITED
Application: ANDA209965
Marketing category: ANDA
Marketing start: 2020-02-10
Marketing end: 0000-00-00
Substance: FOSAPREPITANT DIMEGLUMINE
Active strength: 150 mg/5mL
Pharmacologic classes: Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69539-181		D	Discontinued by firm		2026-08-07
excluded package	package	69539-181	69539-181-01	D	Discontinued by firm		2026-08-07

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	69539-181		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69539-181	69539-181-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A209965-001	FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2019-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209965-001	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.

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	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209965-001	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209965-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209965-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209965-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209965-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209965-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209965-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209965-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209965-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209965-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209965-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209965-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209965-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209965-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209965-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209965-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209965-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209965-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209965-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209965-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209965-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209965-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209965-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209965-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209965-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209965-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209965-001	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209965-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209965-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209965-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209965-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209965-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209965-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209965-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209965-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209965-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209965-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209965-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209965-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209965-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209965-001	AP	1	`a50c72e98297…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69539-181	FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MSN LABORATORIES PRIVATE LIMITED]	2	Legacy NDC	20221013_82dccc4a-5eb1-4741-b6bc-4bf5797a204b.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosaprepitant	FOSAPREPITANT	Northstar Rx LLC	bf207918-100d-4917-88b0-3433c0e72249	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209965 application number: ANDA209965
Fosaprepitant	FOSAPREPITANT	Bryant Ranch Prepack	679c195a-cf59-4ca5-aa05-fa35d08ddb5c	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209965 application number: ANDA209965
Fosaprepitant	FOSAPREPITANT	BluePoint Laboratories	ad89825f-aa31-469f-9685-159a4524dfdc	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209965 application number: ANDA209965
Fosaprepitant	FOSAPREPITANT	Dr. Reddy's Laboratories Inc.,	f34c931c-78b9-90c1-3fa5-bb34a227f2ad	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209965 application number: ANDA209965
Fosaprepitant	FOSAPREPITANT	Novadoz Pharmaceuticals LLC	1e6b36b2-3c8b-4ac4-827e-d6f00d999032	2022-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209965 application number: ANDA209965
Fosaprepitant	FOSAPREPITANT	Novadoz Pharmaceuticals LLC	a7343abe-b2b0-4e5a-907b-532a8e16dfcb	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209965 application number: ANDA209965
Fosaprepitant	FOSAPREPITANT	Dr. Reddy's Laboratories Inc.,	d624667d-ee3b-3501-53fe-da453352042d	2020-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209965 application number: ANDA209965

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D35FM8T64X	FOSAPREPITANT DIMEGLUMINE	265121-04-8	FOSAPREPITANT DIMEGLUMINE
6L8OF9XRDC	FOSAPREPITANT	172673-20-0	Fosaprepitant

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69539-181-01	69539018101	1 VIAL, SINGLE-DOSE in 1 CARTON (69539-181-01) > 5 mL in 1 VIAL, SINGLE-DOSE	2020-02-10	0000-00-00	No	No	Current