Kit for the Prepartion of Technetium Tc99m Sulfur Colloid

Product NDC: 45567-0030
11-digit product format: 455670030
Labeler code: 45567
Product ID: 45567-0030_22078227-b702-2e8c-e063-6294a90aeb67
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Technetium Tc 99m Sulfur Colloid
Dosage form: KIT
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA017858
Marketing category: NDA
Marketing start: 1978-04-19
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
N017858-001	AN-SULFUR COLLOID	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017858-001	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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017858-001	AN-SULFUR COLLOID	N/A	SOLUTION / INJECTION, ORAL		RLD, RS, Approved before 1982	`f41ea6bd6efb…`

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	N017858-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017858-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017858-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017858-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017858-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017858-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017858-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017858-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017858-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017858-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017858-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017858-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017858-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017858-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017858-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017858-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017858-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017858-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017858-001	AP	1	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017858-001	AP	1	`a50c72e98297…`

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	N017858-001	ODE-29	2019-08-13	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N017858-001	ODE-29	2019-08-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017858-001	ODE-29	2019-08-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017858-001	ODE-29	2019-08-13	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Kit for the Prepartion of Technetium Tc99m Sulfur Colloid
Listing expiration: 2026-12-31

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
eeaf70fd-46bd-4fec-ba9d-2366fdf07888	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45567-0030-1	Kit for the Prepartion of Technetium Tc99m Sulfur Colloid	1 in 1 PACKAGE	KIT	1		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45567-0030-1	EA - Each	45567-0030	f4bf02aa-35ce-4dd9-8169-869199a17aa4	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TECHNETIUM TC-99M SULFUR COLLOID	ACTIVE INGREDIENT	556Q0P6PB1	KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID (TECHNETIUM TC 99M SULFUR COLLOID) KIT [PHARMALUCENCE INC.]	6
TECHNETIUM TC-99M SULFUR COLLOID	ACTIVE MOIETY	556Q0P6PB1	KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID (TECHNETIUM TC 99M SULFUR COLLOID) KIT [PHARMALUCENCE INC.]	6
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID (TECHNETIUM TC 99M SULFUR COLLOID) KIT [PHARMALUCENCE INC.]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID (TECHNETIUM TC 99M SULFUR COLLOID) KIT [PHARMALUCENCE INC.]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID (TECHNETIUM TC 99M SULFUR COLLOID) KIT [PHARMALUCENCE INC.]	6
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS	INACTIVE INGREDIENT	KH7I04HPUU	KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID (TECHNETIUM TC 99M SULFUR COLLOID) KIT [PHARMALUCENCE INC.]	6
SODIUM THIOSULFATE ANHYDROUS	INACTIVE INGREDIENT	L0IYT1O31N	KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID (TECHNETIUM TC 99M SULFUR COLLOID) KIT [PHARMALUCENCE INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45567-0030	KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID (TECHNETIUM TC 99M SULFUR COLLOID) KIT [SUN PHARMACEUTICAL INDUSTRIES, INC.]	14	Current NDC, Legacy NDC, 1 package rows	20240915_eeaf70fd-46bd-4fec-ba9d-2366fdf07888.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
Kit for the Prepartion of Technetium Tc99m Sulfur Colloid	TECHNETIUM TC 99M SULFUR COLLOID	Sun Pharmaceutical Industries, Inc.	eeaf70fd-46bd-4fec-ba9d-2366fdf07888	2024-09-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017858 application number: NDA017858 ndc (product): 45567-0030

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45567-0030-1	45567003001	1 KIT in 1 PACKAGE (45567-0030-1) * 3 mL in 1 VIAL * 3 mL in 1 VIAL * 10 mL in 1 VIAL	1 kit	1978-04-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Kit for the Prepartion of Technetium Tc99m Sulfur Colloid	Sun Pharmaceutical Industries, Inc.	2024-09-13	HUMAN PRESCRIPTION DRUG LABEL	14