CODEINE AND CHLORPHENIRAMINE MALEATE ER

Product NDC: 0722-7184
11-digit product format: 007227184
Labeler code: 0722
Product ID: 0722-7184_6feb059d-5153-42a5-9306-6b05429ca86d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CODEINE AND CHLORPHENIRAMINE MALEATE ER
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Nexgen Pharma, Inc.
Application: NDA206323
Marketing category: NDA
Marketing start: 2015-09-01
Marketing end: 0000-00-00
Substance: CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE
Active strength: 54 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
DEA schedule: CIII
NDC exclude flag: E
Listing certified through: 2018-12-31
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	0722-7184		I	Inactivated by FDA		2026-08-11
excluded package	package	0722-7184	0722-7184-01	I	Inactivated by FDA		2026-08-11

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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0722-7184-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0722-7184-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0722-7184-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0722-7184-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0722-7184-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0722-7184-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0722-7184-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0722-7184-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0722-7184-01	I	Inactivated by FDA	`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	0722-7184-01	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	0722-7184-01	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	0722-7184-01	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	0722-7184-01	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	0722-7184-01	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	0722-7184-01	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	0722-7184-01	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	0722-7184-01	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	0722-7184-01	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	0722-7184-01	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	0722-7184-01	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	0722-7184-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0722-7184-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
N206323-001	TUXARIN ER	CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL			2015-06-22

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206323-001	9066942	2032-01-03	U-1716		2015-07-20
N206323-001	9107921	2032-01-03		Drug product	2015-09-17

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206323-001	TUXARIN ER	8MG;54.3MG	TABLET, EXTENDED RELEASE / ORAL	2015-06-22	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206323-001	6383471	2019-04-06	U-1716	Drug product	2015-07-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206323-001	6248363	2019-11-23	U-1716	Drug product	2015-07-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206323-001	9066942	2032-01-03	U-1716		2015-07-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206323-001	9107921	2032-01-03		Drug product	2015-09-17	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
09d8330d-4fec-be98-3a66-f985140646b2	Product name	2	20210513
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
e9576821-a971-5261-628e-82ad9e10acdb	Product name	2	20150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
ce055423-1d7f-3c41-dff1-83660fa8cd96	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0722-7184-01	2020-01-31	C162847	48780-1	9d75b9d0-28a2-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE™ safely and effectively. See full prescribing information for CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE. CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE (codeine phosphate and chlorpheniramine maleate) extended release tablets, CIII Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0722-7184-01	CODEINE AND CHLORPHENIRAMINE MALEATE ER	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.]	1
CODEINE PHOSPHATE	ACTIVE INGREDIENT	GSL05Y1MN6	CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.]	1
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.]	1
CODEINE ANHYDROUS	ACTIVE MOIETY	UX6OWY2V7J	CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.]	1
HYPROMELLOSE 2208 (4000 MPA.S)	INACTIVE INGREDIENT	39J80LT57T	CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0722-7184	CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE [NEXGEN PHARMA, INC.]	7	Legacy NDC, 1 package rows	20170210_f3114cff-d638-4562-9e11-88130677363c.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
Tuxarin	CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE	Mainpointe Pharmaceuticals	a7cfab67-6087-4ab4-b7cd-4f9295413180	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 206323 application number: NDA206323

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GSL05Y1MN6	CODEINE PHOSPHATE	41444-62-6	CODEINE PHOSPHATE
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1664543	codeine phosphate 54.3 MG / chlorpheniramine maleate 8 MG 12HR Oral Extended Release Tablet	PSN	f3114cff-d638-4562-9e11-88130677363c	7
1664543	12 HR chlorpheniramine maleate 8 MG / codeine phosphate 54.3 MG Extended Release Oral Tablet	SCD	f3114cff-d638-4562-9e11-88130677363c	7
1664543	chlorpheniramine maleate 8 MG / codeine phosphate 54.3 MG 12HR Oral Extended Release Tablet	SY	f3114cff-d638-4562-9e11-88130677363c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
0722-7184-01	00722718401	100 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CODEINE AND CHLORPHENIRAMINE MALEATE ER	Nexgen Pharma, Inc. \| Spiraso LLC	2017-01-20	HUMAN PRESCRIPTION DRUG LABEL	7