Kit for the Preparation of Technetium Tc 99m Sulfur Colloid

Product NDC: 65174-179
11-digit product format: 651740179
Labeler code: 65174
Product ID: 65174-179_92a1bc37-cc23-4498-ad61-29347c3876dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Technetium Tc 99m Sulfur Colloid Kit
Dosage form: KIT
Labeler: Jubilant DraxImage Inc., dba Jubilant Radiopharma
Application: ANDA213516
Marketing category: ANDA
Marketing start: 2023-12-04
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
A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP		2023-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213516-001	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
2026-09-14 22:38:34	2026-08	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213516-001	TECHNETIUM TC-99M SULFUR COLLOID KIT	N/A	SOLUTION / INJECTION, ORAL	AP	2023-11-09	`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	A213516-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213516-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213516-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213516-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213516-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213516-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213516-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213516-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213516-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213516-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213516-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213516-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213516-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213516-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213516-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213516-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213516-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213516-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213516-001	AP	1	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213516-001	AP	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213516-001	CGT	2024-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213516-001	CGT	2024-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213516-001	CGT	2024-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213516-001	CGT	2024-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213516-001	CGT	2024-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213516-001	CGT	2024-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213516-001	CGT	2024-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213516-001	CGT	2024-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213516-001	CGT	2024-06-01	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213516-001	CGT	2024-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213516-001	CGT	2024-06-01	`1c564ffb4f44…`

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: Kit for the Preparation of Technetium Tc 99m 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
f756e00e-0acd-4c5d-97f8-ed57f23a2393	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65174-179-01	Kit for the Preparation of Technetium Tc 99m Sulfur Colloid	1 in 1 PACKAGE	KIT	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65174-179	KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SULFUR COLLOID (TECHNETIUM TC 99M SULFUR COLLOID KIT) KIT [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA]	6	Current NDC, 1 package rows	20231207_f756e00e-0acd-4c5d-97f8-ed57f23a2393.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 Preparation of Technetium Tc 99m Sulfur Colloid	TECHNETIUM TC 99M SULFUR COLLOID KIT	Jubilant DraxImage Inc., dba Jubilant Radiopharma	f756e00e-0acd-4c5d-97f8-ed57f23a2393	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213516 application number: ANDA213516 ndc (product): 65174-179

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
65174-179-01	65174017901	1 KIT in 1 PACKAGE (65174-179-01) * 3 mL in 1 VIAL (65174-046-01) * 3 mL in 1 VIAL (65174-047-01) * 10 mL in 1 VIAL (65174-131-01)	1 kit	2023-12-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid	Jubilant DraxImage Inc., dba Jubilant Radiopharma \| Jubilant HollistierStier LLC	2023-12-05	HUMAN PRESCRIPTION DRUG LABEL	6