FDA.reportPublic FDA data

Application 215252

Type
NDA
Sponsor
EXELA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDESOLUTION;INTRAVENOUS125MG/125ML (1MG/ML)NoNo
002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDESOLUTION;INTRAVENOUS250MG/250ML (1MG/1ML)NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%DILTIAZEM HYDROCHLORIDE125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-28
N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%DILTIAZEM HYDROCHLORIDE250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-28

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 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2021-10-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-10-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-10-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-10-28782e0a99824c…
2021-12-28 21:50 UTC2021-12N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2021-10-28782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N215252-001DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%125MG/125ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-286a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N215252-002DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2021-10-286a51e52b5d6a…

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 6 · 113 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackec928ee5-0809-4ba5-82ca-ecfed99ebb5a2026-07-21Warnings, Adverse reactionsName fallback
brand name: diltiazem hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEMajor Pharmaceuticalse7476adc-a940-4e76-a1dd-c418de493bc02026-07-14Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackfb6a6199-bb70-476e-a2a2-b7594c9c001a2026-07-10Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEAmerican Health Packaging11b43a17-8038-462b-8902-259431ad52562026-06-22Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutions465dbab3-f201-4441-8f55-92a843b5134f2026-06-19Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEGolden State Medical Supply, Inc.c9f17187-e958-106b-e053-2a95a90a54d82026-06-16Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack50df9f09-aa2f-495d-a25c-7c5c0fdffcf02026-05-27Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHospira, Inc.bba03666-ff4f-4bf6-fa92-78e1ec2d90732026-05-24Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack76e04232-b3da-48e8-a944-5f4f97a508df2026-05-13Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEUpsher-Smith Laboratories, LLCf276d9fe-a685-4d99-ad82-d4452ef4ba982026-05-08Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENorthstar Rx LLCe2511ffe-5821-4f64-a469-f8ef9618b1b52026-05-05Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEZydus Lifesciences Limited8329d0ac-d68c-48d2-9cbc-e1a1b60192d92026-05-01Name fallback
brand name: Diltiazem hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Cartia XTDILTIAZEM HYDROCHLORIDEActavis Pharma, Inc.2dc2b889-8443-4f7f-83be-86c68e1798042026-04-30Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAlembic Pharmaceuticals Inc.04a85be5-f746-418e-8e37-292703f169342026-04-29Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDECardinal Health 107, LLCbdb9e7cf-bfbb-48b4-a8be-9038820d82792026-04-23Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEREMEDYREPACK INC.5e935265-d0fc-4223-835f-72426eeea6c42026-04-10Warnings, Adverse reactionsName fallback
brand name: diltiazem hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEPreferred Pharmaceuticals Inc.3d594530-885f-45c7-b8a5-fd7e503ff83f2026-04-06Warnings, Adverse reactionsName fallback
brand name: diltiazem hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEUpsher-Smith Laboratories, LLCbb32d681-9a83-431e-9984-a5cee2c948522026-04-01Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDESlate Run Pharmaceuticals, LLCf7137458-0db3-7ecd-e053-6394a90a5f952026-03-27Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutions839af3af-4040-4cf4-8d4a-881a053514cc2026-03-17Warnings, Adverse reactionsName fallback
brand name: Diltiazem Hydrochloride
generic name: DILTIAZEM HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51754-3000DILTIAZEM HYDROCHLORIDEdiltiazem hydrochlorideExela Pharma Sciences,LLCNDACurrent
51754-3500DILTIAZEM HYDROCHLORIDEdiltiazem hydrochlorideExela Pharma Sciences,LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71706ORIG2022-08-04
69159ORIG2021-10-29
69156ORIG2021-10-29