SUSTOL

Product NDC: 47426-101
11-digit product format: 474260101
Labeler code: 47426
Product ID: 47426-101_d4d4e836-ebba-4666-b6da-9d5a846dfcf8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: granisetron
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Heron Therapeutics, Inc.
Application: NDA022445
Marketing category: NDA
Marketing start: 2016-08-09
Substance: GRANISETRON
Active strength: 10 mg/.4mL
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	47426-101	47426-101-01	D	Discontinued by firm		2026-08-17

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	47426-101-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	47426-101-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	47426-101-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	47426-101-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	47426-101-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	47426-101-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	47426-101-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	47426-101-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	47426-101-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	47426-101-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	47426-101-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	47426-101-06	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	47426-101-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N022445-001	SUSTOL	GRANISETRON	10MG/0.4ML (10MG/0.4ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2016-08-09

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2016-08-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2016-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2016-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2016-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2016-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2016-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2016-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2016-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2016-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2016-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTABLE / SUBCUTANEOUS	RLD, RS	2016-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022445-001	SUSTOL	10MG/0.4ML (10MG/0.4ML)	INJECTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2016-08-09	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 192 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022445-001	10357570	2024-09-28	U-2253		2019-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022445-001	8252304	2024-09-28		Drug product	2016-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022445-001	8252305	2024-09-28	U-1891		2016-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022445-001	8715710	2024-09-28		Drug product	2016-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022445-001	9913910	2024-09-28	U-2253		2018-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022445-001	10357570	2024-09-28	U-2253		2019-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022445-001	8252304	2024-09-28		Drug product	2016-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022445-001	8252305	2024-09-28	U-1891		2016-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022445-001	8715710	2024-09-28		Drug product	2016-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022445-001	9913910	2024-09-28	U-2253		2018-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022445-001	10357570	2024-09-28	U-2253		2019-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022445-001	8252304	2024-09-28		Drug product	2016-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022445-001	8252305	2024-09-28	U-1891		2016-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022445-001	8715710	2024-09-28		Drug product	2016-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022445-001	9913910	2024-09-28	U-2253		2018-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022445-001	10357570	2024-09-28	U-2253		2019-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022445-001	8252304	2024-09-28		Drug product	2016-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022445-001	8252305	2024-09-28	U-1891		2016-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022445-001	8715710	2024-09-28		Drug product	2016-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022445-001	9913910	2024-09-28	U-2253		2018-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022445-001	10357570	2024-09-28	U-2253		2019-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022445-001	8252304	2024-09-28		Drug product	2016-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022445-001	8252305	2024-09-28	U-1891		2016-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022445-001	8715710	2024-09-28		Drug product	2016-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022445-001	9913910	2024-09-28	U-2253		2018-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022445-001	10357570	2024-09-28	U-2253		2019-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022445-001	8252304	2024-09-28		Drug product	2016-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022445-001	8252305	2024-09-28	U-1891		2016-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022445-001	8715710	2024-09-28		Drug product	2016-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022445-001	9913910	2024-09-28	U-2253		2018-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022445-001	10357570	2024-09-28	U-2253		2019-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022445-001	8252304	2024-09-28		Drug product	2016-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022445-001	8252305	2024-09-28	U-1891		2016-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022445-001	8715710	2024-09-28		Drug product	2016-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022445-001	9913910	2024-09-28	U-2253		2018-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022445-001	10357570	2024-09-28	U-2253		2019-07-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022445-001	8252304	2024-09-28		Drug product	2016-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022445-001	8252305	2024-09-28	U-1891		2016-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022445-001	8715710	2024-09-28		Drug product	2016-08-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022445-001	9913910	2024-09-28	U-2253		2018-03-28	`1e350fbaab3a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022445-001	NDF	2019-08-09	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022445-001	NDF	2019-08-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022445-001	NDF	2019-08-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022445-001	NDF	2019-08-09	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: SUSTOL
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GRANISETRON	10 mg/.4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WZG3J2MCOL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1810484	Internal RxNorm lookup
1810489	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
f7c7ffdd-8270-4030-bc1e-a1cb28a6de56	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cfd5f35c-827b-432c-9fef-0869f8899c80	Product name	1	20260105
bd0ef290-bb63-6056-ab17-adf968a44900	Product name	2	20170616
d7be5b36-17f0-843a-22b1-df15cb96e594	Product name	3	20170616
e5d20d92-e4d9-43c9-9475-8f368311d104	Product name	2	20170501
5a6fb99e-671a-4b1d-a9dc-1e7566682136	Product name	1	20160831
5c6cdff6-4525-6e4a-2964-09019d52be11	Product name	1	20140508
ae524849-1812-2c3b-219e-58a687215e77	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
47426-101-01	2024-10-06	These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993
47426-101-01	2024-10-06	These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993
47426-101-01	2024-10-06	These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993
47426-101-06	2024-10-06	These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993
47426-101-06	2024-10-06	These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993
47426-101-06	2024-10-06	These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993
47426-101-01	2024-07-30	These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993
47426-101-01	2024-07-30	These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993
47426-101-01	2024-07-30	These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993
47426-101-06	2024-07-30	These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993
47426-101-06	2024-07-30	These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993
47426-101-06	2024-07-30	These highlights do not include all the information needed to use SUSTOL ® safely and effectively. See full prescribing information for SUSTOL. SUSTOL ® (granisetron) extended-release injection, for subcutaneous use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
47426-101-01	SUSTOL	1 in 1 KIT	INJECTION	1	10
47426-101-01	SUSTOL	1 in 1 CARTON	INJECTION	1	10
47426-101-06	SUSTOL	6 in 1 CARTON	INJECTION	6	10
47426-101-06	SUSTOL	1 in 1 KIT	INJECTION	1	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47426-101-01	ML - Milliliter	47426-101	01baefcf-7671-4c9f-9d32-69806574e9a2	1	2016-11-08
47426-101-06	ML - Milliliter	47426-101	ffb74299-59b1-4f50-8675-a69fc101d4fe	1	2016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47426-101	SUSTOL (GRANISETRON) INJECTION [HERON THERAPEUTICS, INC.]	7	Current NDC, Legacy NDC, 4 package rows	20241008_f7c7ffdd-8270-4030-bc1e-a1cb28a6de56.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
SUSTOL	GRANISETRON	Heron Therapeutics, Inc.	f7c7ffdd-8270-4030-bc1e-a1cb28a6de56	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022445 application number: NDA022445 ndc (product): 47426-101

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WZG3J2MCOL	GRANISETRON	109889-09-0	GRANISETRON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1810484	granisetron 10 MG in 0.4 ML Prefilled Syringe	PSN	f7c7ffdd-8270-4030-bc1e-a1cb28a6de56	10
1810489	sustol 10 MG in 0.4 ML Prefilled Syringe	PSN	f7c7ffdd-8270-4030-bc1e-a1cb28a6de56	10
1810489	0.4 ML granisetron 25 MG/ML Prefilled Syringe [Sustol]	SBD	f7c7ffdd-8270-4030-bc1e-a1cb28a6de56	10
1810484	0.4 ML granisetron 25 MG/ML Prefilled Syringe	SCD	f7c7ffdd-8270-4030-bc1e-a1cb28a6de56	10
1810489	0.4 ML Sustol 25 MG/ML Prefilled Syringe	SY	f7c7ffdd-8270-4030-bc1e-a1cb28a6de56	10
1810484	granisetron 10 MG per 0.4 ML Prefilled Syringe	SY	f7c7ffdd-8270-4030-bc1e-a1cb28a6de56	10
1810489	Sustol 10 MG per 0.4 ML Prefilled Syringe	SY	f7c7ffdd-8270-4030-bc1e-a1cb28a6de56	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47426-101-01	47426010101	1 in 1 KIT						Historical
47426-101-06	47426010106	6 KIT in 1 CARTON (47426-101-06) / 1 SYRINGE, GLASS in 1 KIT / .4 mL in 1 SYRINGE, GLASS	6 kit	2016-08-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SUSTOL	Heron Therapeutics, Inc. \| Wavelength Enterprises LTD \| INKE, S.A. \| Lifecore Biomedical	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	11