Moxifloxacin

Product NDC
0904-6406
11-digit product format
009046406
Labeler code
0904
Product ID
0904-6406_5347c7e3-120f-408d-9cb3-b8f42fed655d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Moxifloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA076938
Marketing category
ANDA
Marketing start
2014-03-05
Marketing end
0000-00-00
Substance
MOXIFLOXACIN HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC], Quinolones [CS]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0904-6406DDiscontinued by firm2026-08-17
excluded packagepackage0904-64060904-6406-04DDiscontinued by firm2026-08-17
excluded packagepackage0904-64060904-6406-06DDiscontinued 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 packagepackage0904-6406-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-6406-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-6406-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-6406-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-6406-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-6406-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-6406-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-6406-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-6406-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-6406-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-6406-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-6406-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-6406-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-6406-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-6406-06ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-6406-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-6406-060efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-6406-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-6406-06ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-6406-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-6406-06367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-6406-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-6406-06557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-6406-04557ba5c1ecfa…9c80585c8c6e…

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

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
A076938-001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076938-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-043f01610625f2…
2019-09-15 20:21 UTC2019-09A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076938-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALABRS2014-03-04e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076938-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076938-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076938-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076938-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076938-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076938-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076938-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076938-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076938-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076938-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076938-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076938-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076938-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076938-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076938-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076938-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076938-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076938-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076938-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076938-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076938-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076938-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076938-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076938-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076938-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076938-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076938-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076938-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076938-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076938-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076938-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076938-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076938-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076938-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076938-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076938-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076938-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076938-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076938-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076938-001AB1e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6406-04EA - Each0904-640600387c98-6c50-474e-86e9-32cc16a6af8712019-03-12
0904-6406-06EA - Each0904-64061ef00e93-a049-415a-94f6-b49f4c67ff1612014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MOXIFLOXACIN HYDROCHLORIDEACTIVE INGREDIENTC53598599TMOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
MOXIFLOXACINACTIVE MOIETYU188XYD42PMOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMOXIFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MoxifloxacinMOXIFLOXACINPD-Rx Pharmaceuticals, Inc.1c6f7150-a8f4-408f-956f-c26d37030cf42025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076938
application number: ANDA076938
MoxifloxacinMOXIFLOXACINBryant Ranch Prepackd20ba997-30de-445c-8766-924112bd834a2023-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076938
application number: ANDA076938
MoxifloxacinMOXIFLOXACINDr. Reddy's Laboratories Limited71b02da1-3175-1db8-192a-c0a8a6cd98a52020-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076938
application number: ANDA076938

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6406-040090464060430 BLISTER PACK in 1 CARTON (0904-6406-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2014-03-050000-00-00NoNoCurrent
0904-6406-060090464060650 BLISTER PACK in 1 CARTON (0904-6406-06) > 1 TABLET, FILM COATED in 1 BLISTER PACK50 blister pack2014-03-050000-00-00NoNoCurrent