FDA.reportPublic FDA data

Application 218038

Type
NDA
Sponsor
HQ SPCLT PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDEDILTIAZEM HYDROCHLORIDESOLUTION;INTRAVENOUS100MG/100ML (1MG/ML)YesYes
002DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDEDILTIAZEM HYDROCHLORIDESOLUTION;INTRAVENOUS250MG/250ML (1MG/ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N218038-001DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDEDILTIAZEM HYDROCHLORIDE100MG/100ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-21
N218038-002DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDEDILTIAZEM HYDROCHLORIDE250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-21

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N218038-001DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE100MG/100ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-2184e616aacf4f…
2026-09-14 22:38:342026-08N218038-002DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-2184e616aacf4f…
2026-08-18 06:07:402026-07N218038-001DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE100MG/100ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07N218038-002DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218038-001DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE100MG/100ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218038-002DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218038-001DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE100MG/100ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218038-002DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N218038-001DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE100MG/100ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218038-002DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218038-001DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE100MG/100ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218038-002DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-21fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218038-001DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE100MG/100ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218038-002DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE250MG/250ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-21a50c72e98297…

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 4 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEIngenus Pharmaceuticals, LLC355f560a-8ebb-4661-ad74-2a22f707d7f82025-06-17Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
TIADYLT ERDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackb4b4e53e-fc99-4f34-abc2-57e4f28aff842025-06-13Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc044f774-783f-4920-a8a1-6d4b1b3820c12025-06-11Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Cartia XTDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackde671934-25a8-4df6-b7a1-97e0337e9e2b2025-06-02Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDETeva Pharmaceuticals USA, Inc.69ca7cae-fdf3-413a-900b-95cf6e9e7b632025-05-30Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDESun Pharmaceutical Industries, Inc.976d9dd0-4f11-4439-b84e-0c0f0e018d8b2025-05-22Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEViona Pharmaceuticals Inc43cffe12-304a-4e15-9512-94f812188f1a2025-05-05Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
TIADYLT ERDILTIAZEM HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.1278cd76-b8e9-42d9-ad19-6858e72cf9f22025-05-02Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
TIADYLT ERDILTIAZEM HYDROCHLORIDEZydus Lifesciences Limitedd88e3546-3984-4dc9-893a-a29e958045502025-05-02Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDECoupler LLC3418eb02-117e-a71a-e063-6394a90a826e2025-05-01Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.1e2f2025-0350-40c4-ab42-3b57f3d105a62025-05-01Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEActavis Pharma, Inc.178eec1f-1d4d-4a38-b66a-d3ba3de06c3d2025-05-01Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEZydus Lifesciences Limitedfe790439-85d4-4cd8-a385-149ea3442a382025-05-01Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
CardizemDILTIAZEM HYDROCHLORIDEBausch Health US LLCf3e7ecef-f360-4987-a4f5-933214130ab22025-04-30Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEIngenus Pharmaceuticals, LLC64401d2a-bd5b-43fd-879a-e9d16345e8272025-04-17Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEAvKARE31e63a95-9e62-01c8-e063-6294a90af0e12025-04-03Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Cartia XTDILTIAZEM HYDROCHLORIDEBryant Ranch Prepacke02f5fad-6482-4d5d-91c5-0ae6b0ce15b82025-03-06Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDECoupler LLC2ced821f-19a6-4c7e-e063-6394a90adb802025-01-30Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDECoupler LLC2cd92b83-075e-b069-e063-6294a90a9fff2025-01-29Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
CARTIA XTDILTIAZEM HYDROCHLORIDEDirectRxdbfda3a5-5602-6e47-e053-2995a90ac07b2025-01-22Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84172ORIG 2025-11-17
81363ORIG 2025-02-25
81330ORIG 2025-02-24