nebivolol

Product NDC
0904-7225
11-digit product format
009047225
Labeler code
0904
Product ID
0904-7225_13c6911b-c653-4fa9-87ea-3e505bf3ba34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA203966
Marketing category
ANDA
Marketing start
2018-03-02
Marketing end
0000-00-00
Substance
NEBIVOLOL HYDROCHLORIDE
Active strength
3 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
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 productproduct0904-7225DDiscontinued by firm2026-08-11
excluded packagepackage0904-72250904-7225-04DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0904-7225DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-72250904-7225-04DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203966-001NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORAL2018-03-02
A203966-002NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2018-03-02
A203966-003NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2018-03-02
A203966-004NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2018-03-02

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203966-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203966-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203966-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203966-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2018-03-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203966-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203966-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203966-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203966-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2018-03-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203966-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203966-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203966-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203966-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2018-03-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203966-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203966-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203966-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203966-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2018-03-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203966-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203966-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203966-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203966-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2018-03-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203966-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203966-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203966-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203966-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2018-03-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203966-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203966-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203966-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203966-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2018-03-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203966-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203966-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203966-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203966-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2018-03-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203966-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-03-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203966-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-03-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203966-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-03-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203966-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2018-03-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203966-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-03-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A203966-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-03-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A203966-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-03-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A203966-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2018-03-02d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203966-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203966-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203966-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203966-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203966-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203966-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203966-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203966-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203966-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203966-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203966-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203966-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203966-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203966-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203966-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203966-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203966-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203966-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203966-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203966-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203966-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203966-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203966-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203966-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203966-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203966-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203966-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203966-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203966-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203966-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203966-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203966-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203966-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203966-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203966-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203966-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203966-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203966-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203966-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203966-004AB1d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7225-04EA - Each0904-72251aad2323-e975-4a11-beaa-375293fc2a9812022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7225NEBIVOLOL TABLET [MAJOR PHARMACEUTICALS]7Legacy NDC20250321_1a3b660c-1a31-4240-9d7b-1e04225459f3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7225-040090472250430 BLISTER PACK in 1 CARTON (0904-7225-04) > 1 TABLET in 1 BLISTER PACK30 blister pack2018-03-020000-00-00NoNoCurrent