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 3 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAmerican Health Packaging14869f9e-6a66-4f75-b0fc-4d808b1ee85e2025-11-13Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Cardizem LADILTIAZEM HYDROCHLORIDEBausch Health US LLC3e180dc7-c871-4efc-8755-cae882976c8d2025-11-11Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack58eeb8bc-91d0-4cf8-a0d7-be3548d921962025-11-11Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEEugia US LLCf8d962ab-6cd4-43a1-a8fa-fb6548ac2a082025-11-07Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEMedical Purchasing Solutions, LLC41d75325-d935-ba54-e063-6394a90aade22025-10-23Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack22e653e5-4122-4d7d-b9ad-0bdc1390fb402025-10-20Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEScieGen Pharmaceuticals, Inc.1ca03c9e-edc8-4c7f-89ee-f2346ea8c0672025-10-16Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEScieGen Pharmaceuticals, Inc196fc367-330e-4d15-b1d6-084ad3f97ae72025-10-15Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem Hydrochloride EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEOceanside Pharmaceuticals862d65cb-a732-4786-b569-bad2eaafddfd2025-10-13Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAccord Healthcare, Inc.70293a05-d314-43fa-a2b1-398cfb39edf82025-10-09Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc8809dc9-b99b-4d30-a7da-0bc21aa90f9c2025-10-02Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEProPharma Distribution3f2942d7-f4d0-2d77-e063-6294a90a74ad2025-09-18Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc1ef9e90-6ff0-4ee5-86a3-1efee9c367892025-09-16Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEAlembic Pharmaceuticals Inc.ac9aa10d-cd52-4ac9-a01d-e3cbf14d49132025-08-30Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepacke6d9397c-f8a2-42d6-88ca-55060b1d073a2025-08-26Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack9041cc05-29d2-41ca-a368-e953bf3443b52025-08-25Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack0089fc7a-a7aa-4873-b699-39a1b21616ca2025-08-20Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDECipla USA, Inc.bce61158-201d-458c-be0c-9bdd2d3a0bec2025-08-01Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEOCEANSIDE PHARMACEUTICALS43892b97-449d-45bc-bb09-29d47c655d652025-07-31Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEMylan Institutional Inc.9942f1a2-f66d-4d9e-9794-49bee8abf5ab2025-07-18Warnings, 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