FDA.reportPublic FDA data

Tuxarin

Product NDC
71269-040
11-digit product format
712690040
Labeler code
71269
Product ID
71269-040_c64324ef-f77f-4467-844a-711a6b305582
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
codeine phosphate and chlorpheniramine maleate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Mainpointe Pharmaceuticals
Application
NDA206323
Marketing category
NDA
Marketing start
2018-10-15
Substance
CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE
Active strength
8; 54.3 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N206323-001TUXARIN ERCHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206323-00190669422032-01-03U-17162015-07-20
N206323-00191079212032-01-03Drug product2015-09-17

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-223f01610625f2…
2019-09-15 20:21 UTC2019-09N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22b00525d2431f…
2019-07-19 19:46 UTC2019-07N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N206323-001TUXARIN ER8MG;54.3MGTABLET, EXTENDED RELEASE / ORAL2015-06-22cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N206323-00190669422032-01-03U-17162015-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206323-00191079212032-01-03Drug product2015-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206323-00190669422032-01-03U-17162015-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206323-00191079212032-01-03Drug product2015-09-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N206323-00190669422032-01-03U-17162015-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206323-00191079212032-01-03Drug product2015-09-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206323-00190669422032-01-03U-17162015-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206323-00191079212032-01-03Drug product2015-09-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206323-00190669422032-01-03U-17162015-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206323-00191079212032-01-03Drug product2015-09-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206323-00190669422032-01-03U-17162015-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206323-00191079212032-01-03Drug product2015-09-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206323-00190669422032-01-03U-17162015-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206323-00191079212032-01-03Drug product2015-09-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206323-00190669422032-01-03U-17162015-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206323-00191079212032-01-03Drug product2015-09-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206323-00190669422032-01-03U-17162015-07-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206323-00191079212032-01-03Drug product2015-09-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206323-00190669422032-01-03U-17162015-07-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N206323-00191079212032-01-03Drug product2015-09-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206323-00190669422032-01-03U-17162015-07-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206323-00191079212032-01-03Drug product2015-09-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206323-00190669422032-01-03U-17162015-07-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206323-00191079212032-01-03Drug product2015-09-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206323-00190669422032-01-03U-17162015-07-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206323-00191079212032-01-03Drug product2015-09-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206323-00190669422032-01-03U-17162015-07-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05N206323-00191079212032-01-03Drug product2015-09-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206323-00190669422032-01-03U-17162015-07-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206323-00191079212032-01-03Drug product2015-09-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206323-00190669422032-01-03U-17162015-07-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N206323-00191079212032-01-03Drug product2015-09-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206323-00190669422032-01-03U-17162015-07-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N206323-00191079212032-01-03Drug product2015-09-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N206323-00163834712019-04-06U-1716Drug product2015-07-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206323-00162483632019-11-23U-1716Drug product2015-07-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206323-00190669422032-01-03U-17162015-07-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206323-00191079212032-01-03Drug product2015-09-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N206323-00190669422032-01-03U-17162015-07-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N206323-00191079212032-01-03Drug product2015-09-17bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Tuxarin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CODEINE PHOSPHATE8 mg/1
CHLORPHENIRAMINE MALEATE54.3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GSL05Y1MN6Internal UNII lookup
V1Q0O9OJ9ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1664543Internal RxNorm lookup
2099286Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7cfab67-6087-4ab4-b7cd-4f9295413180Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71269-040-102023-06-22These highlights do not include all the information needed to use TUXARIN ER™ safely and effectively. See full prescribing information for TUXARIN ER. TUXARIN ER (codeine phosphate and chlorpheniramine maleate) extended-release tablets, for oral use, CIII Initial U.S. Approval: 1985
71269-040-302023-06-22These highlights do not include all the information needed to use TUXARIN ER™ safely and effectively. See full prescribing information for TUXARIN ER. TUXARIN ER (codeine phosphate and chlorpheniramine maleate) extended-release tablets, for oral use, CIII Initial U.S. Approval: 1985
71269-040-102023-01-30These highlights do not include all the information needed to use TUXARIN ER™ safely and effectively. See full prescribing information for TUXARIN ER. TUXARIN ER (codeine phosphate and chlorpheniramine maleate) extended-release tablets, for oral use, CIII Initial U.S. Approval: 1985
71269-040-302023-01-30These highlights do not include all the information needed to use TUXARIN ER™ safely and effectively. See full prescribing information for TUXARIN ER. TUXARIN ER (codeine phosphate and chlorpheniramine maleate) extended-release tablets, for oral use, CIII Initial U.S. Approval: 1985
71269-040-102021-11-18These highlights do not include all the information needed to use TUXARIN ER™ safely and effectively. See full prescribing information for TUXARIN ER. TUXARIN ER (codeine phosphate and chlorpheniramine maleate) extended-release tablets, for oral use, CIII Initial U.S. Approval: 1985
71269-040-102021-01-29These highlights do not include all the information needed to use TUXARIN ER™ safely and effectively. See full prescribing information for TUXARIN ER. TUXARIN ER (codeine phosphate and chlorpheniramine maleate) extended-release tablets, for oral use, CIII Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71269-040-10Tuxarin100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1006
71269-040-30Tuxarin30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71269-040-10EA - Each71269-04099a6e027-60cf-46b6-9497-9073736cf2f412019-03-12
71269-040-30EA - Each71269-04000252566-1d84-456a-93c5-b8c8e3cb6f4e12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71269-040TUXARIN (CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE) TABLET, EXTENDED RELEASE [MAINPOINTE PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20240119_a7cfab67-6087-4ab4-b7cd-4f9295413180.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TuxarinCODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATEMainpointe Pharmaceuticalsa7cfab67-6087-4ab4-b7cd-4f92954131802024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 206323
application number: NDA206323
ndc (product): 71269-040

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1664543codeine phosphate 54.3 MG / chlorpheniramine maleate 8 MG 12HR Oral Extended Release TabletPSNa7cfab67-6087-4ab4-b7cd-4f92954131806
2099286Tuxarin ER 54.3 MG / 8 MG 12HR Extended Release Oral TabletPSNa7cfab67-6087-4ab4-b7cd-4f92954131806
209928612 HR chlorpheniramine maleate 8 MG / codeine phosphate 54.3 MG Extended Release Oral Tablet [Tuxarin]SBDa7cfab67-6087-4ab4-b7cd-4f92954131806
166454312 HR chlorpheniramine maleate 8 MG / codeine phosphate 54.3 MG Extended Release Oral TabletSCDa7cfab67-6087-4ab4-b7cd-4f92954131806
1664543chlorpheniramine maleate 8 MG / codeine phosphate 54.3 MG 12HR Oral Extended Release TabletSYa7cfab67-6087-4ab4-b7cd-4f92954131806
2099286Tuxarin 54.3 MG / 8 MG 12 HR Extended Release Oral TabletSYa7cfab67-6087-4ab4-b7cd-4f92954131806

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71269-040-1071269004010100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-10) 2018-10-150000-00-00NoNoCurrent
71269-040-307126900403030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-30) 2018-10-150000-00-00NoNoCurrent