Welchol

Product NDC: 21695-781
11-digit product format: 216950781
Labeler code: 21695
Product ID: 21695-781_fc274f83-4cd6-47bd-b43e-53a0bf345f11
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: colesevelam hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA021176
Marketing category: NDA
Marketing start: 2000-09-01
Marketing end: 0000-00-00
Substance: COLESEVELAM HYDROCHLORIDE
Active strength: 625 mg/1
Pharmacologic classes: Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]
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	21695-781		I	Inactivated by FDA		2026-08-17
excluded package	package	21695-781	21695-781-78	I	Inactivated by FDA		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 · 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	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	21695-781-78	`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	21695-781-78	`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	21695-781-78	`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	21695-781-78	`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	21695-781-78	`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	21695-781-78	`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	21695-781-78	`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	21695-781-78	`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	21695-781-78	`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	21695-781-78	`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	21695-781-78	`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	21695-781-78	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-781-78	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-781-78	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-781-78	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-781-78	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-781-78	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-781-78	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-781-78	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-781-78	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-781-78	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-781-78	`110d247fa046…`	`a55b01930146…`

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
N021176-001	WELCHOL	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021176-001	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 2 · 42 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
2026-08-18 06:07:40	2026-07	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021176-001	WELCHOL	625MG	TABLET / ORAL	AB	RLD, RS	2000-05-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021176-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021176-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021176-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021176-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021176-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021176-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021176-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021176-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021176-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021176-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021176-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021176-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021176-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021176-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021176-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021176-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021176-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021176-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021176-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021176-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021176-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021176-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021176-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021176-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021176-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021176-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021176-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021176-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021176-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021176-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021176-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021176-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021176-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021176-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021176-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021176-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021176-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021176-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021176-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021176-001	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021176-001	7229613	2022-04-17	U-851		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021176-001	7229613	2022-04-17	U-851		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021176-001	7229613	2022-04-17	U-851		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021176-001	7229613	2022-04-17	U-851		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021176-001	7229613	2022-04-17	U-851		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021176-001	7229613	2022-04-17	U-851		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021176-001	7229613	2022-04-17	U-851		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021176-001	7229613	2022-04-17	U-851		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021176-001	7229613	2022-04-17	U-851		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021176-001	7229613	2022-04-17	U-851		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021176-001	7229613	2022-04-17	U-851		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021176-001	7229613	2022-04-17	U-851		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021176-001	7229613	2022-04-17	U-851		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021176-001	7229613	2022-04-17	U-851		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021176-001	7229613	2022-04-17	U-851		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021176-001	7229613	2022-04-17	U-851		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021176-001	7229613	2022-04-17	U-851		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021176-001	7229613	2022-04-17	U-851		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021176-001	7229613*PED	2022-10-17		Pediatric extension	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
78368210-61ea-2003-e774-9745708f5823	Product name	9	20220328

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-781-78	2019-09-24	C162847	48780-1	934fe258-4b36-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use Welchol safely and effectively. See full prescribing information for Welchol. Welchol (colesevelam hydrochloride) Tablet, Film Coated, for Oral Welchol (colesevelam hydrochloride) For Suspension, for Oral Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-781-78	Welchol	180 in 1 BOTTLE	TABLET, FILM COATED	180		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-781-78	EA - Each	21695-781	0dc3c492-6cfc-4edd-bb9f-5ecc5e436518	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COLESEVELAM HYDROCHLORIDE	ACTIVE INGREDIENT	P4SG24WI5Q	WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
COLESEVELAM	ACTIVE MOIETY	1XU104G55N	WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES	INACTIVE INGREDIENT	U72Q2I8C85	WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM TRISILICATE	INACTIVE INGREDIENT	C2E1CI501T	WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL ALGINATE	INACTIVE INGREDIENT	26CD3J2R0C	WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-781	WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110127_fc274f83-4cd6-47bd-b43e-53a0bf345f11.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	A-S Medication Solutions	0127afae-8d8d-43f2-97f9-4f99f6947e81	2023-12-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021176 application number: NDA021176
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	A-S Medication Solutions	40d66c9d-ff51-4353-8133-ae3a8eb4f713	2023-12-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021176 application number: NDA021176

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P4SG24WI5Q	COLESEVELAM HYDROCHLORIDE	182815-44-7	COLESEVELAM HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866905	colesevelam HCl 3.75 GM Powder for Oral Suspension	PSN	fc274f83-4cd6-47bd-b43e-53a0bf345f11	1
866910	colesevelam HCl 625 MG Oral Tablet	PSN	fc274f83-4cd6-47bd-b43e-53a0bf345f11	1
866907	Welchol 3.75 GM Powder for Oral Suspension	PSN	fc274f83-4cd6-47bd-b43e-53a0bf345f11	1
866912	Welchol 625 MG Oral Tablet	PSN	fc274f83-4cd6-47bd-b43e-53a0bf345f11	1
866907	colesevelam hydrochloride 3750 MG Powder for Oral Suspension [Welchol]	SBD	fc274f83-4cd6-47bd-b43e-53a0bf345f11	1
866912	colesevelam hydrochloride 625 MG Oral Tablet [Welchol]	SBD	fc274f83-4cd6-47bd-b43e-53a0bf345f11	1
866905	colesevelam hydrochloride 3750 MG Powder for Oral Suspension	SCD	fc274f83-4cd6-47bd-b43e-53a0bf345f11	1
866910	colesevelam hydrochloride 625 MG Oral Tablet	SCD	fc274f83-4cd6-47bd-b43e-53a0bf345f11	1
866905	colesevelam HCl 3.75 GM Powder for Oral Suspension	SY	fc274f83-4cd6-47bd-b43e-53a0bf345f11	1
866907	Welchol 3.75 GM Powder for Oral Suspension	SY	fc274f83-4cd6-47bd-b43e-53a0bf345f11	1
866907	Welchol 3750 MG Powder for Oral Suspension	SY	fc274f83-4cd6-47bd-b43e-53a0bf345f11	1
866912	Welchol 625 MG Oral Tablet	SY	fc274f83-4cd6-47bd-b43e-53a0bf345f11	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-781-78	21695078178	180 in 1 BOTTLE	Historical