Carvedilol Phosphate

Product NDC
0115-1249
11-digit product format
001151249
Labeler code
0115
Product ID
0115-1249_ad7423a5-e5c2-4a50-a338-c25370dba2a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARVEDILOL PHOSPHATE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA204717
Marketing category
ANDA
Marketing start
2024-01-01
Substance
CARVEDILOL PHOSPHATE
Active strength
20 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

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
A204717-001CARVEDILOL PHOSPHATECARVEDILOL PHOSPHATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07
A204717-002CARVEDILOL PHOSPHATECARVEDILOL PHOSPHATE20MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07
A204717-003CARVEDILOL PHOSPHATECARVEDILOL PHOSPHATE40MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07
A204717-004CARVEDILOL PHOSPHATECARVEDILOL PHOSPHATE80MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204717-001AB
A204717-002AB
A204717-003AB
A204717-004AB

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 · 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 UTC2026-02A204717-001CARVEDILOL PHOSPHATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204717-002CARVEDILOL PHOSPHATE20MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204717-003CARVEDILOL PHOSPHATE40MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204717-004CARVEDILOL PHOSPHATE80MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204717-001CARVEDILOL PHOSPHATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204717-002CARVEDILOL PHOSPHATE20MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204717-003CARVEDILOL PHOSPHATE40MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204717-004CARVEDILOL PHOSPHATE80MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204717-001CARVEDILOL PHOSPHATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204717-002CARVEDILOL PHOSPHATE20MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204717-003CARVEDILOL PHOSPHATE40MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204717-004CARVEDILOL PHOSPHATE80MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204717-001CARVEDILOL PHOSPHATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204717-002CARVEDILOL PHOSPHATE20MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204717-003CARVEDILOL PHOSPHATE40MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204717-004CARVEDILOL PHOSPHATE80MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204717-001CARVEDILOL PHOSPHATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204717-002CARVEDILOL PHOSPHATE20MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204717-003CARVEDILOL PHOSPHATE40MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204717-004CARVEDILOL PHOSPHATE80MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204717-001CARVEDILOL PHOSPHATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204717-002CARVEDILOL PHOSPHATE20MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204717-003CARVEDILOL PHOSPHATE40MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204717-004CARVEDILOL PHOSPHATE80MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204717-001CARVEDILOL PHOSPHATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204717-002CARVEDILOL PHOSPHATE20MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204717-003CARVEDILOL PHOSPHATE40MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204717-004CARVEDILOL PHOSPHATE80MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204717-001CARVEDILOL PHOSPHATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204717-002CARVEDILOL PHOSPHATE20MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204717-003CARVEDILOL PHOSPHATE40MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204717-004CARVEDILOL PHOSPHATE80MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204717-001CARVEDILOL PHOSPHATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204717-002CARVEDILOL PHOSPHATE20MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204717-003CARVEDILOL PHOSPHATE40MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204717-004CARVEDILOL PHOSPHATE80MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204717-001CARVEDILOL PHOSPHATE10MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A204717-002CARVEDILOL PHOSPHATE20MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A204717-003CARVEDILOL PHOSPHATE40MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A204717-004CARVEDILOL PHOSPHATE80MGCAPSULE, EXTENDED RELEASE / ORALAB2018-05-07d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204717-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204717-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204717-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204717-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204717-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204717-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204717-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204717-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204717-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204717-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204717-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204717-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204717-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204717-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204717-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204717-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204717-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204717-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204717-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204717-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204717-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204717-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204717-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204717-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204717-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204717-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204717-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204717-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204717-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204717-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204717-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204717-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204717-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204717-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204717-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204717-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204717-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204717-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204717-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204717-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL PHOSPHATE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EQT531S367Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
860510Internal RxNorm lookup
860516Internal RxNorm lookup
860522Internal RxNorm lookup
860532Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fa6b4014-e9d7-4074-95fc-4b48d91da83bAvailable 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
0115-1249-01Carvedilol Phosphate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10016
0115-1249-03Carvedilol Phosphate1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100016
0115-1249-08Carvedilol Phosphate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3016
0115-1249-10Carvedilol Phosphate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1249-08EA - Each0115-12494a3701c3-01b6-439a-b05e-a1b270ab89e512024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1249CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]16Current NDC, Legacy NDC, 4 package rows20250503_fa6b4014-e9d7-4074-95fc-4b48d91da83b.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carvedilol PhosphateCARVEDILOL PHOSPHATEAvKARE1be1b5d2-eb2c-1d02-e063-6294a90adbba2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204717
application number: ANDA204717
Carvedilol PhosphateCARVEDILOL PHOSPHATEAmneal Pharmaceuticals NY LLCdbec7c4b-3db7-4c9d-b5da-e72050ee57432025-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204717
application number: ANDA204717
Carvedilol PhosphateCARVEDILOL PHOSPHATEAmneal Pharmaceuticals of New York LLCfa6b4014-e9d7-4074-95fc-4b48d91da83b2025-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204717
application number: ANDA204717
ndc (product): 0115-1249

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860510carvedilol phosphate 10 MG 24HR Extended Release Oral CapsulePSNfa6b4014-e9d7-4074-95fc-4b48d91da83b16
860516carvedilol phosphate 20 MG 24HR Extended Release Oral CapsulePSNfa6b4014-e9d7-4074-95fc-4b48d91da83b16
860522carvedilol phosphate 40 MG 24HR Extended Release Oral CapsulePSNfa6b4014-e9d7-4074-95fc-4b48d91da83b16
860532carvedilol phosphate 80 MG 24HR Extended Release Oral CapsulePSNfa6b4014-e9d7-4074-95fc-4b48d91da83b16
86051024 HR carvedilol phosphate 10 MG Extended Release Oral CapsuleSCDfa6b4014-e9d7-4074-95fc-4b48d91da83b16
86051624 HR carvedilol phosphate 20 MG Extended Release Oral CapsuleSCDfa6b4014-e9d7-4074-95fc-4b48d91da83b16
86052224 HR carvedilol phosphate 40 MG Extended Release Oral CapsuleSCDfa6b4014-e9d7-4074-95fc-4b48d91da83b16
86053224 HR carvedilol phosphate 80 MG Extended Release Oral CapsuleSCDfa6b4014-e9d7-4074-95fc-4b48d91da83b16
860510carvedilol phosphate 10 MG 24 HR Extended Release Oral CapsuleSYfa6b4014-e9d7-4074-95fc-4b48d91da83b16
860516carvedilol phosphate 20 MG 24 HR Extended Release Oral CapsuleSYfa6b4014-e9d7-4074-95fc-4b48d91da83b16
860522carvedilol phosphate 40 MG 24 HR Extended Release Oral CapsuleSYfa6b4014-e9d7-4074-95fc-4b48d91da83b16
860532carvedilol phosphate 80 MG 24 HR Extended Release Oral CapsuleSYfa6b4014-e9d7-4074-95fc-4b48d91da83b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-1249-0100115124901100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-01) 2024-01-010000-00-00NoNoCurrent
0115-1249-03001151249031000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-03) 2024-01-010000-00-00NoNoCurrent
0115-1249-080011512490830 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-08) 2024-01-010000-00-00NoNoCurrent
0115-1249-100011512491090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1249-10) 2024-01-010000-00-00NoNoCurrent