OsmoPrep

Product NDC: 65649-701
11-digit product format: 656490701
Labeler code: 65649
Product ID: 65649-701_e6edede7-3573-41d4-ab6f-afeb62355815
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUS
Dosage form: TABLET
Route: ORAL
Labeler: Salix Pharmaceuticals, Inc.
Application: NDA021892
Marketing category: NDA
Marketing start: 2006-05-15
Marketing end: 0000-00-00
Substance: SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
Active strength: 1 g/1; g/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65649-701		D	Discontinued by firm	2026-08-03
excluded package	package	65649-701	65649-701-32	D	Discontinued by firm	2026-08-03
excluded package	package	65649-701	65649-701-41	D	Discontinued by firm	2026-08-03

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65649-701-41	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65649-701-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65649-701-41	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65649-701-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65649-701-41	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65649-701-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65649-701-41	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65649-701-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65649-701-41	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65649-701-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65649-701-41	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65649-701-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65649-701-41	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65649-701-32	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65649-701-41	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65649-701-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65649-701-41	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65649-701-32	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65649-701-41	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65649-701-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65649-701-41	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65649-701-32	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65649-701-41	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65649-701-32	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N021892-001	OSMOPREP	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	0.398GM;1.102GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-03-16

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021892-001	7687075	2028-06-22		Drug substance, Drug product

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021892-001	OSMOPREP	0.398GM;1.102GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021892-001	OSMOPREP	0.398GM;1.102GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021892-001	OSMOPREP	0.398GM;1.102GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021892-001	OSMOPREP	0.398GM;1.102GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021892-001	OSMOPREP	0.398GM;1.102GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021892-001	OSMOPREP	0.398GM;1.102GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021892-001	OSMOPREP	0.398GM;1.102GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021892-001	OSMOPREP	0.398GM;1.102GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021892-001	OSMOPREP	0.398GM;1.102GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021892-001	OSMOPREP	0.398GM;1.102GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL		RLD	2006-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL		RLD	2006-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL		RLD	2006-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL		RLD	2006-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL	AB	RLD, RS	2006-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL	AB	RLD, RS	2006-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL	AB	RLD, RS	2006-03-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL		RLD, RS	2006-03-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL	AB	RLD, RS	2006-03-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL	AB	RLD, RS	2006-03-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL	AB	RLD, RS	2006-03-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL	AB	RLD, RS	2006-03-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL		RLD, RS	2006-03-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL		RLD, RS	2006-03-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL		RLD, RS	2006-03-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL		RLD, RS	2006-03-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL		RLD, RS	2006-03-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL		RLD	2006-03-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL		RLD	2006-03-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL		RLD	2006-03-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL		RLD	2006-03-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL		RLD	2006-03-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL	AB	RLD, RS	2006-03-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL	AB	RLD, RS	2006-03-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL	AB	RLD, RS	2006-03-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL	AB	RLD, RS	2006-03-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL	AB	RLD, RS	2006-03-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL	AB	RLD, RS	2006-03-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL	AB	RLD, RS	2006-03-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021892-001	OSMOPREP	0.398GM;1.102GM	TABLET / ORAL	AB	RLD, RS	2006-03-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021892-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021892-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021892-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021892-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021892-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021892-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021892-001	AB	1	`5aa47cf7b7d7…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021892-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021892-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021892-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021892-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021892-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021892-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021892-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021892-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021892-001	7687075	2028-06-22	Drug substance, Drug product	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65649-701-41	EA - Each	65649-701	f112338e-0e6e-48c9-8898-f605c81e5e69	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	ACTIVE INGREDIENT	22ADO53M6F	OSMOPREP (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUS) TABLET [SALIX PHARMACEUTICALS, INC.]	20
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	ACTIVE INGREDIENT	593YOG76RN	OSMOPREP (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUS) TABLET [SALIX PHARMACEUTICALS, INC.]	20
PHOSPHATE ION	ACTIVE MOIETY	NK08V8K8HR	OSMOPREP (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUS) TABLET [SALIX PHARMACEUTICALS, INC.]	20
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OSMOPREP (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUS) TABLET [SALIX PHARMACEUTICALS, INC.]	20
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	OSMOPREP (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUS) TABLET [SALIX PHARMACEUTICALS, INC.]	20
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	ACTIVE INGREDIENT	22ADO53M6F	OSMOPREP (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUS) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	ACTIVE INGREDIENT	593YOG76RN	OSMOPREP (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUS) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	OSMOPREP (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUS) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OSMOPREP (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUS) TABLET [PHYSICIANS TOTAL CARE, INC.]	3
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	OSMOPREP (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUS) TABLET [PHYSICIANS TOTAL CARE, INC.]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
593YOG76RN	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	10049-21-5	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
22ADO53M6F	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	7558-79-4	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
636141	OsmoPrep 1.5 GM Oral Tablet	PSN	983ce15f-cd37-4f3a-9e51-205860e80976	3
603011	sodium phosphate 1.5 GM Oral Tablet	PSN	983ce15f-cd37-4f3a-9e51-205860e80976	3
636141	sodium phosphate 1500 MG Oral Tablet [OsmoPrep]	SBD	983ce15f-cd37-4f3a-9e51-205860e80976	3
603011	sodium phosphate 1500 MG Oral Tablet	SCD	983ce15f-cd37-4f3a-9e51-205860e80976	3
636141	OsmoPrep 1500 MG Oral Tablet	SY	983ce15f-cd37-4f3a-9e51-205860e80976	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65649-701-41	65649070141	100 TABLET in 1 BOTTLE, PLASTIC (65649-701-41)	100 tablet	2006-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OsmoPrep	Salix Pharmaceuticals, Inc. \| Novel Laboratories, Inc. \| Carton Service	2019-03-04	HUMAN PRESCRIPTION DRUG LABEL	31
OsmoPrep - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-06-04	HUMAN PRESCRIPTION DRUG LABEL	3