Carvedilol

Product NDC
65862-142
11-digit product format
658620142
Labeler code
65862
Product ID
65862-142_f210723f-29fb-46c7-8ac4-5009d9696d3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078332
Marketing category
ANDA
Marketing start
2007-09-05
Substance
CARVEDILOL
Active strength
3.125 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
unfinished productproduct65862-142UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage65862-14265862-142-71UNFINISHEDActive or certified unfinished drug listing2026-08-17

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 · 42 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 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-142-71a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-142-711d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-142-71390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-142-71e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-142-71bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-142-71f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-142-71f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-142-7168b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-142-7105c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-142-7148b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-142-7127f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-142-718d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-142-71d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-142-7150b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-142-71906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-142-716db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-142-718fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-142-714184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-142-714bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-142-71263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproduct5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage65862-142-715b2001dcd8f5…54b53d4dc9e4…

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

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
A078332-001CARVEDILOLCARVEDILOL3.125MGTABLET / ORALAB2007-09-05
A078332-002CARVEDILOLCARVEDILOL6.25MGTABLET / ORALAB2007-09-05
A078332-003CARVEDILOLCARVEDILOL12.5MGTABLET / ORALAB2007-09-05
A078332-004CARVEDILOLCARVEDILOL25MGTABLET / ORALAB2007-09-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A078332-001AB
A078332-002AB
A078332-003AB
A078332-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078332-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078332-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078332-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Carvedilol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL3.125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0K47UL67F2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200031Internal RxNorm lookup
200032Internal RxNorm lookup
200033Internal RxNorm lookup
686924Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7cc14b86-0833-4c3c-91f3-7963d7052fd5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-142-01Carvedilol100 in 1 BOTTLETABLET, FILM COATED10023
65862-142-05Carvedilol500 in 1 BOTTLETABLET, FILM COATED50023
65862-142-99Carvedilol1000 in 1 BOTTLETABLET, FILM COATED100023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-142-01EA - Each65862-142ccb2ae82-f124-4b3f-ba99-c64b1daf175112013-02-13
65862-142-05EA - Each65862-1429302c000-1921-4df3-bd27-14414e26c25912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
carvedilolACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-142CARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]23Current NDC, Legacy NDC, 3 package rows20240608_7cc14b86-0833-4c3c-91f3-7963d7052fd5.zip

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.0930965b-80e3-4a0c-bffc-14ac32a478942025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.2be8635b-5733-1ed4-e054-00144ff88e882025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.8640adde-d071-44a4-97d0-fa8a8548debe2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.205da5d0-05d9-440d-bb5a-b30b826900ab2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLA-S Medication Solutionsf5969d18-46c7-4f35-9668-2fd4f6bbeb172025-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLBryant Ranch Prepackfe4aa7f0-6ef2-4a95-8a64-5e3365f104742024-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLNuCare Pharmaceuticals,Inc.786e8ad3-a8d7-41e6-e053-2991aa0a32c72024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLAurobindo Pharma Limited7cc14b86-0833-4c3c-91f3-7963d7052fd52024-06-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
ndc (product): 65862-142
CarvedilolCARVEDILOLProficient Rx LPcd7e7c34-6958-47be-a1c1-f1ed948e26872022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLProficient Rx LP36230cc8-e808-4f74-a27d-4367eecd21f72022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLProficient Rx LP55a19ff1-f8c1-4cf0-8711-9bfa32756de92020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLAphena Pharma Solutions - Tennessee, LLCd0089df4-37c8-41de-810c-14c9dc06f0c32018-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686924carvedilol 3.125 MG Oral TabletPSN8640adde-d071-44a4-97d0-fa8a8548debe27
686924carvedilol 3.125 MG Oral TabletSCD8640adde-d071-44a4-97d0-fa8a8548debe27
200032carvedilol 12.5 MG Oral TabletPSN7cc14b86-0833-4c3c-91f3-7963d7052fd523
200033carvedilol 25 MG Oral TabletPSN7cc14b86-0833-4c3c-91f3-7963d7052fd523
686924carvedilol 3.125 MG Oral TabletPSN7cc14b86-0833-4c3c-91f3-7963d7052fd523
200031carvedilol 6.25 MG Oral TabletPSN7cc14b86-0833-4c3c-91f3-7963d7052fd523
200032carvedilol 12.5 MG Oral TabletSCD7cc14b86-0833-4c3c-91f3-7963d7052fd523
200033carvedilol 25 MG Oral TabletSCD7cc14b86-0833-4c3c-91f3-7963d7052fd523
686924carvedilol 3.125 MG Oral TabletSCD7cc14b86-0833-4c3c-91f3-7963d7052fd523
200031carvedilol 6.25 MG Oral TabletSCD7cc14b86-0833-4c3c-91f3-7963d7052fd523
200032carvedilol 12.5 MG Oral TabletPSN4d56592a-d9be-441c-9200-eab9018ec31213
200033carvedilol 25 MG Oral TabletPSN4d56592a-d9be-441c-9200-eab9018ec31213
686924carvedilol 3.125 MG Oral TabletPSN4d56592a-d9be-441c-9200-eab9018ec31213
200032carvedilol 12.5 MG Oral TabletSCD4d56592a-d9be-441c-9200-eab9018ec31213
200033carvedilol 25 MG Oral TabletSCD4d56592a-d9be-441c-9200-eab9018ec31213
686924carvedilol 3.125 MG Oral TabletSCD4d56592a-d9be-441c-9200-eab9018ec31213
200032carvedilol 12.5 MG Oral TabletPSN213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
200033carvedilol 25 MG Oral TabletPSN213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
686924carvedilol 3.125 MG Oral TabletPSN213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
200031carvedilol 6.25 MG Oral TabletPSN213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
200032carvedilol 12.5 MG Oral TabletSCD213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
200033carvedilol 25 MG Oral TabletSCD213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
686924carvedilol 3.125 MG Oral TabletSCD213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
200031carvedilol 6.25 MG Oral TabletSCD213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
686924carvedilol 3.125 MG Oral TabletPSN55a19ff1-f8c1-4cf0-8711-9bfa32756de94
686924carvedilol 3.125 MG Oral TabletSCD55a19ff1-f8c1-4cf0-8711-9bfa32756de94
200032carvedilol 12.5 MG Oral TabletPSN264a3dc1-596c-43ab-a20c-65c80ab22f2a3
200033carvedilol 25 MG Oral TabletPSN264a3dc1-596c-43ab-a20c-65c80ab22f2a3
686924carvedilol 3.125 MG Oral TabletPSN264a3dc1-596c-43ab-a20c-65c80ab22f2a3
200031carvedilol 6.25 MG Oral TabletPSN264a3dc1-596c-43ab-a20c-65c80ab22f2a3
200032carvedilol 12.5 MG Oral TabletSCD264a3dc1-596c-43ab-a20c-65c80ab22f2a3
200033carvedilol 25 MG Oral TabletSCD264a3dc1-596c-43ab-a20c-65c80ab22f2a3
686924carvedilol 3.125 MG Oral TabletSCD264a3dc1-596c-43ab-a20c-65c80ab22f2a3
200031carvedilol 6.25 MG Oral TabletSCD264a3dc1-596c-43ab-a20c-65c80ab22f2a3
686924carvedilol 3.125 MG Oral TabletPSN8e9b6a2d-ac23-957e-e053-2995a90a817c2
686924carvedilol 3.125 MG Oral TabletSCD8e9b6a2d-ac23-957e-e053-2995a90a817c2
200032carvedilol 12.5 MG Oral TabletPSN62408fc0-65d5-42f6-91a3-2c13f7697b391
200032carvedilol 12.5 MG Oral TabletPSN1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
200033carvedilol 25 MG Oral TabletPSN1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
686924carvedilol 3.125 MG Oral TabletPSN62408fc0-65d5-42f6-91a3-2c13f7697b391
686924carvedilol 3.125 MG Oral TabletPSN1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
686924carvedilol 3.125 MG Oral TabletPSNd0089df4-37c8-41de-810c-14c9dc06f0c31
686924carvedilol 3.125 MG Oral TabletPSN802187fa-e715-9f7c-e053-2991aa0ab7fc1
200031carvedilol 6.25 MG Oral TabletPSN1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
200032carvedilol 12.5 MG Oral TabletSCD1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
200032carvedilol 12.5 MG Oral TabletSCD62408fc0-65d5-42f6-91a3-2c13f7697b391
200033carvedilol 25 MG Oral TabletSCD1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
686924carvedilol 3.125 MG Oral TabletSCDd0089df4-37c8-41de-810c-14c9dc06f0c31
686924carvedilol 3.125 MG Oral TabletSCD802187fa-e715-9f7c-e053-2991aa0ab7fc1
686924carvedilol 3.125 MG Oral TabletSCD62408fc0-65d5-42f6-91a3-2c13f7697b391
686924carvedilol 3.125 MG Oral TabletSCD1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
200031carvedilol 6.25 MG Oral TabletSCD1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-142-0165862014201100 TABLET, FILM COATED in 1 BOTTLE (65862-142-01) 2007-09-050000-00-00NoNoCurrent
65862-142-0565862014205500 TABLET, FILM COATED in 1 BOTTLE (65862-142-05) 2007-09-050000-00-00NoNoCurrent
65862-142-71658620142717000 TABLET, FILM COATED in 1 BAG (65862-142-71)05-SEP-07Current
65862-142-99658620142991000 TABLET, FILM COATED in 1 BOTTLE (65862-142-99) 2007-09-050000-00-00NoNoCurrent