Hydroxyzine Hydrochloride

Product NDC
60429-224
11-digit product format
604290224
Labeler code
60429
Product ID
60429-224_c0963042-9c21-e2a6-e053-2995a90a5720
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply
Application
ANDA040808
Marketing category
ANDA
Marketing start
2008-09-24
Marketing end
0000-00-00
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60429-224DDiscontinued by firm2026-08-17
excluded packagepackage60429-22460429-224-01DDiscontinued by firm2026-08-17
excluded packagepackage60429-22460429-224-10DDiscontinued by firm2026-08-17

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 · 36 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 packagepackage60429-224-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60429-224-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60429-224-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60429-224-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60429-224-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60429-224-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60429-224-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60429-224-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60429-224-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60429-224-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60429-224-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60429-224-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60429-224-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60429-224-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60429-224-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60429-224-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60429-224-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60429-224-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60429-224-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60429-224-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60429-224-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60429-224-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60429-224-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60429-224-10557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040808-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE10MGTABLET / ORAL2008-09-24
A040808-002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE25MGTABLET / ORAL2008-09-24
A040808-003HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL2008-09-24

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040808-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORAL2008-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07A040808-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORAL2008-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07A040808-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORAL2008-09-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040808-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040808-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040808-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040808-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040808-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040808-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A040808-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040808-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040808-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040808-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040808-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040808-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040808-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040808-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040808-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040808-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040808-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040808-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040808-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040808-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040808-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040808-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040808-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040808-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040808-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040808-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040808-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040808-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A040808-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A040808-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040808-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-09-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040808-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-09-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040808-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040808-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-09-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040808-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2008-09-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040808-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2008-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040808-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2008-09-241e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040808-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040808-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040808-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040808-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040808-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040808-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040808-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040808-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040808-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040808-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040808-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040808-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040808-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040808-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040808-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040808-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040808-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040808-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040808-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040808-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040808-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040808-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040808-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040808-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040808-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040808-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040808-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040808-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040808-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040808-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040808-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040808-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040808-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040808-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040808-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040808-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040808-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040808-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040808-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040808-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-224-01EA - Each60429-22412207e98-e673-4621-b392-ea5abc3102bc12013-02-13
60429-224-10EA - Each60429-224d251e313-5a65-45a0-b746-8cd778bf748212013-02-13
60429-224-28EA - Each60429-224edb8ec5e-76a3-4ab1-bf73-29597674593312014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]2

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
Hydroxyzine HydrochlorideHYDROXYZINEAmneal Pharmaceuticals LLC89901966-724b-4773-98b8-ea663ceabd532024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040808
application number: ANDA040808

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-224-0160429022401100 TABLET, FILM COATED in 1 BOTTLE (60429-224-01) 2012-08-120000-00-00NoNoCurrent
60429-224-10604290224101000 TABLET, FILM COATED in 1 BOTTLE (60429-224-10) 2012-08-120000-00-00NoNoCurrent