Active-Medicated specimen collection kit

Product NDC: 45861-107
11-digit product format: 458610107
Labeler code: 45861
Product ID: 45861-107_c6af6fb2-637b-4fa2-8941-7ed78b4eb51a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Urine specimen collection kit
Dosage form: KIT
Labeler: Pharmaceutica North America, Inc
Application: ANDA078010
Marketing category: ANDA
Marketing start: 2013-10-31
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: E
Listing certified through: 2017-12-31
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	45861-107		D	Discontinued by firm		2026-08-10
excluded package	package	45861-107	45861-107-01	D	Discontinued by firm		2026-08-10

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 · 44 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 product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45861-107-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45861-107-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45861-107-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45861-107-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45861-107-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45861-107-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45861-107-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45861-107-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45861-107-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45861-107-01	I	Inactivated by FDA	`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	45861-107-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45861-107-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	45861-107-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	45861-107-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	45861-107-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	45861-107-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	45861-107-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	45861-107-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	45861-107-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	45861-107-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	45861-107-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	45861-107-01	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078010-001	FUROSEMIDE	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18
A078010-002	FUROSEMIDE	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18
A078010-003	FUROSEMIDE	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078010-001	AB
A078010-002	AB
A078010-003	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.

Product history page 1 of 4 · 123 observed 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	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078010-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	2006-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078010-003	FUROSEMIDE	80MG	TABLET / ORAL	AB	2006-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078010-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	2006-09-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078010-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078010-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078010-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078010-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078010-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078010-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078010-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078010-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078010-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078010-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078010-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078010-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078010-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078010-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078010-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078010-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078010-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078010-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078010-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078010-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078010-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078010-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078010-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078010-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078010-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078010-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078010-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078010-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078010-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078010-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078010-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078010-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078010-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078010-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078010-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078010-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078010-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078010-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078010-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078010-001	AB	1	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45861-107-01	2024-12-24	C162847	48780-1	9855e2a2-37ef-60a7-e053-dbdaa90a05bd	Active-Medicated Specimen Collection Kit
45861-107-01	2019-11-27	C162847	48780-1	9855e2a2-37ef-60a7-e053-dbdaa90a05bd	Active-Medicated Specimen Collection Kit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45861-107-01	EA - Each	45861-107	bd39bccd-056a-4e6b-9ed2-746b7fdcf3f7	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	ACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]	11
FUROSEMIDE	ACTIVE INGREDIENT	7LXU5N7ZO5	ACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]	11
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	ACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]	11
FUROSEMIDE	ACTIVE MOIETY	7LXU5N7ZO5	ACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]	11
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]	11
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	INACTIVE INGREDIENT	461P5CJN6T	ACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]	11
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	ACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]	11
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]	11
water	INACTIVE INGREDIENT	059QF0KO0R	ACTIVE-MEDICATED SPECIMEN COLLECTION KIT (URINE SPECIMEN COLLECTION KIT) KIT [PHARMACEUTICA NORTH AMERICA, INC]	11

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	REMEDYREPACK INC.	e8c27f1c-dc81-44b1-8663-a7d663bad89f	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010
Furosemide	FUROSEMIDE	Coupler LLC	4cc2c2d1-2fa4-f6b6-e063-6294a90a290e	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010
Furosemide	FUROSEMIDE	A-S Medication Solutions	ac64c926-88e9-453a-884c-72ec6a1c746a	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010
Furosemide	FUROSEMIDE	A-S Medication Solutions	3f3248cd-d62f-49ca-8788-f059e8facd91	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010
Furosemide	FUROSEMIDE	A-S Medication Solutions	c81d313c-65a3-4fb5-b6cd-b1c1ec7dca03	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010
Furosemide	FUROSEMIDE	A-S Medication Solutions	5d7eb469-2371-4abb-8f49-be1596f10f27	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010
Furosemide	FUROSEMIDE	A-S Medication Solutions	85375079-a9f1-42d4-8e15-c1d31395b29d	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010
Furosemide	FUROSEMIDE	Coupler LLC	3eed4bbf-7d0e-e852-e063-6394a90a85c2	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010
Furosemide	FUROSEMIDE	Ipca Laboratories Limited	0acd293b-ecab-4879-a8e7-cd1b76148f2a	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078010 application number: ANDA078010

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Active-Medicated Specimen Collection Kit	Pharmaceutica North America, Inc \| NuCare Pharmaceuticals \| Professional Disposable International, Inc	2014-03-20	HUMAN PRESCRIPTION DRUG LABEL	11