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 1 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEGolden State Medical Supply, Inc.5a0f67ad-17d8-a3f4-e063-6394a90afb322026-08-27Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDESafecor Health LLCfc02db0f-5311-4b61-896e-bfe3408327352026-08-20Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHF Acquisition Co. LLC DBA HealthFirst59464700-f7f1-6ab0-e063-6394a90aa7782026-08-17Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
TIAZAC EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEBausch Health US, LLCc567fe7e-887e-4291-a0d1-2dd3f25cbf252026-08-07Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDESagent Pharmaceuticals9d51c0f6-26b7-4220-83fb-4e736b289e642026-08-06Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDENORTHSTAR RX LLC56616fc9-f3f7-8e0a-22c8-a6af106e6b1d2026-08-05Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDESlate Run Pharmaceuticals, LLCf7137458-0db3-7ecd-e053-6394a90a5f952026-08-05Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDESlate Run Pharmaceuticals, LLCe66665e8-22eb-f5cd-e053-2a95a90a72e42026-08-05Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackec928ee5-0809-4ba5-82ca-ecfed99ebb5a2026-07-21Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEMajor Pharmaceuticalse7476adc-a940-4e76-a1dd-c418de493bc02026-07-14Warnings, Adverse reactionsName fallback
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
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEGolden State Medical Supply, Inc.c9f17187-e958-106b-e053-2a95a90a54d82026-06-16Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack50df9f09-aa2f-495d-a25c-7c5c0fdffcf02026-05-27Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEHospira, Inc.bba03666-ff4f-4bf6-fa92-78e1ec2d90732026-05-24Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack76e04232-b3da-48e8-a944-5f4f97a508df2026-05-13Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEUpsher-Smith Laboratories, LLCf276d9fe-a685-4d99-ad82-d4452ef4ba982026-05-08Warnings, Adverse reactionsName fallback
generic name: DILTIAZEM HYDROCHLORIDE
Diltiazem hydrochlorideDILTIAZEM HYDROCHLORIDEZydus Lifesciences Limited8329d0ac-d68c-48d2-9cbc-e1a1b60192d92026-05-01Name fallback
generic name: DILTIAZEM HYDROCHLORIDE
Cartia XTDILTIAZEM HYDROCHLORIDEActavis Pharma, Inc.2dc2b889-8443-4f7f-83be-86c68e1798042026-04-30Warnings, 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