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 5 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem Hydrochloride EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc7c6a74e-5f73-4265-a0e0-8fd2cd26909e2025-01-21Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAlembic Pharmaceuticals Limitedd9c5c1ed-1a9d-494c-b798-9da09ba1fe1b2024-12-26Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAlembic Pharmaceuticals Limited61b9ca82-7d41-4f49-b4a0-549c9473c4472024-10-30Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutions88b150a6-4c8d-49c8-88df-f3606c3354722024-10-28Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs70f167a1-ec7f-4969-b446-166af3e52c052024-09-13Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs74620be9-5120-491a-a171-e50612c065412024-09-13Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEDr. Reddy's Labratories Inc.f1d09c53-5eb9-0b7c-e977-e2a602e84e5f2024-08-19Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENuCare Pharmaceuticals,Inc.54b0b11d-adc0-4afb-e054-00144ff88e882024-07-17Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEChartwell RX, LLC51abce7b-e3d1-44b5-bccc-d463150d0bba2024-06-19Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENuCare Pharmaceuticals,Inc.7cdb473a-e6d5-48e8-e053-2a91aa0aaeb72024-06-12Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDENuCare Pharmaceuticals,Inc.636556f6-2987-984f-e053-2991aa0a201a2024-06-06Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackfe7ca564-16b8-4c54-aa09-3e2ed0c2596a2024-05-17Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutionsf317de31-495c-4268-8171-89534bf1dd362024-05-07Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHikma Pharmaceuticals USA Inc.453b73bd-c52d-4d72-a0b3-47588e723e0b2024-04-09Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackde2a0c48-7fc4-4760-b465-a79299876e6e2024-04-05Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack74232d69-1a8c-449d-8e8e-85488e6cc8f82024-04-03Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack6ca6a648-fc67-4cf8-a1f7-787c9574e3a12024-03-27Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack0e9b4421-bc43-4a77-b49b-e3f53d1e0f012024-01-10Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepacka6cc3b99-2c0f-4d8a-8393-ec042ed7c8922024-01-10Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride Extended-ReleaseDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack2cc8c9c5-a81a-4fb8-a8a4-bc717318c8a62024-01-10Warnings, 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