Gonak Hypromellose

Product NDC
17478-064
11-digit product format
174780064
Labeler code
17478
Product ID
17478-064_7804e6db-6cc3-4d9c-a5fe-df0a8279350c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hypromellose 2906 (4000 MPA.S) and Hypromellose 2906 (50 MPA.S)
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Akorn
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1997-01-01
Marketing end
0000-00-00
Substance
HYPROMELLOSE 2906 (4000 MPA.S); HYPROMELLOSE 2906 (50 MPA.S)
Active strength
25 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct17478-064DDiscontinued by firm2026-08-11
excluded packagepackage17478-06417478-064-12DDiscontinued by firm2026-08-11

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 · 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 packagepackage17478-064-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17478-064-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17478-064-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17478-064-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17478-064-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17478-064-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17478-064-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17478-064-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17478-064-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17478-064-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17478-064-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17478-064-12557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-064-12ML - Milliliter17478-0641b221145-bb1e-440f-b5f9-33b62ae4ef7a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hypromellose 2906 (4000 MPA.S)ACTIVE INGREDIENT5EYA69XGATGONAK HYPROMELLOSE (HYPROMELLOSE 2906 (4000 MPA.S) AND HYPROMELLOSE 2906 (50 MPA.S)) SOLUTION [AKORN, INC.]1
Hypromellose 2906 (50 MPA.S)ACTIVE INGREDIENT612E703ZUQGONAK HYPROMELLOSE (HYPROMELLOSE 2906 (4000 MPA.S) AND HYPROMELLOSE 2906 (50 MPA.S)) SOLUTION [AKORN, INC.]1
Hypromellose 2906 (4000 MPA.S)ACTIVE MOIETY5EYA69XGATGONAK HYPROMELLOSE (HYPROMELLOSE 2906 (4000 MPA.S) AND HYPROMELLOSE 2906 (50 MPA.S)) SOLUTION [AKORN, INC.]1
Hypromellose 2906 (50 MPA.S)ACTIVE MOIETY612E703ZUQGONAK HYPROMELLOSE (HYPROMELLOSE 2906 (4000 MPA.S) AND HYPROMELLOSE 2906 (50 MPA.S)) SOLUTION [AKORN, INC.]1
boric acidINACTIVE INGREDIENTR57ZHV85D4GONAK HYPROMELLOSE (HYPROMELLOSE 2906 (4000 MPA.S) AND HYPROMELLOSE 2906 (50 MPA.S)) SOLUTION [AKORN, INC.]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KGONAK HYPROMELLOSE (HYPROMELLOSE 2906 (4000 MPA.S) AND HYPROMELLOSE 2906 (50 MPA.S)) SOLUTION [AKORN, INC.]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBGONAK HYPROMELLOSE (HYPROMELLOSE 2906 (4000 MPA.S) AND HYPROMELLOSE 2906 (50 MPA.S)) SOLUTION [AKORN, INC.]1
potassium chlorideINACTIVE INGREDIENT660YQ98I10GONAK HYPROMELLOSE (HYPROMELLOSE 2906 (4000 MPA.S) AND HYPROMELLOSE 2906 (50 MPA.S)) SOLUTION [AKORN, INC.]1
sodium borateINACTIVE INGREDIENT91MBZ8H3QOGONAK HYPROMELLOSE (HYPROMELLOSE 2906 (4000 MPA.S) AND HYPROMELLOSE 2906 (50 MPA.S)) SOLUTION [AKORN, INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IGONAK HYPROMELLOSE (HYPROMELLOSE 2906 (4000 MPA.S) AND HYPROMELLOSE 2906 (50 MPA.S)) SOLUTION [AKORN, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RGONAK HYPROMELLOSE (HYPROMELLOSE 2906 (4000 MPA.S) AND HYPROMELLOSE 2906 (50 MPA.S)) SOLUTION [AKORN, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-064-12174780064121 VIAL in 1 CARTON (17478-064-12) > 15 mL in 1 VIAL1 vial1997-01-010000-00-00NoNoCurrent