ZUTRIPRO

Product NDC
63717-876
11-digit product format
637170876
Labeler code
63717
Product ID
63717-876_4ed25d38-27e1-4ee4-92b5-d3af4dbac6be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Hawthorn Pharmaceuticals, Inc.
Application
NDA022439
Marketing category
NDA
Marketing start
2011-06-08
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active strength
5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2019-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63717-876DDiscontinued by firm2026-08-10
excluded packagepackage63717-87663717-876-16DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63717-876-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63717-876-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63717-876-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63717-876-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63717-876-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63717-876-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63717-876-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63717-876-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63717-876-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63717-876-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63717-876-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63717-876-16557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022439-001ZUTRIPROCHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-08

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 UTC2026-02N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5MLSOLUTION / ORALRLD2011-06-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5MLSOLUTION / ORALRLD2011-06-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5MLSOLUTION / ORALRLD2011-06-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**SOLUTION / ORALRLD2011-06-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5MLSOLUTION / ORALRLD2011-06-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5MLSOLUTION / ORALRLD2011-06-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5MLSOLUTION / ORALRLD2011-06-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5MLSOLUTION / ORALRLD2011-06-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5MLSOLUTION / ORALRLD2011-06-083f01610625f2…
2019-09-15 20:21 UTC2019-09N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5MLSOLUTION / ORALRLD2011-06-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5MLSOLUTION / ORALAARLD, RS2011-06-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022439-001ZUTRIPRO4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2011-06-08cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07N022439-001AA1ea99ee380514…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63717-876-16ML - Milliliter63717-87663049ebf-e747-48ee-93c0-692e648edfea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7ZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4
GRAPEINACTIVE INGREDIENT6X543N684KZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554ZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RZUTRIPRO (HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [HAWTHORN PHARMACEUTICALS, INC.]4