Home NDC 70436-196 Diltiazem Hydrochloride
Product NDC 70436-196
11-digit product format 704360196
Labeler code 70436
Product ID 70436-196_58494981-80ca-63f9-e063-6294a90aef59
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diltiazem Hydrochloride
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA216439
Marketing category ANDA
Marketing start 2023-03-20
Substance DILTIAZEM HYDROCHLORIDE
Active strength 180 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216439-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 A216439-002 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 A216439-003 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 A216439-004 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 A216439-005 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 A216439-006 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 4 · 156 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A216439-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A216439-002 DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A216439-003 DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A216439-004 DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A216439-005 DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A216439-006 DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 c2088c7a36db…2026-09-14 22:38:34 2026-08 A216439-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216439-002 DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216439-003 DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216439-004 DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216439-005 DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216439-006 DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216439-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216439-002 DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216439-003 DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216439-004 DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216439-005 DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216439-006 DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216439-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216439-002 DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216439-003 DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216439-004 DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216439-005 DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216439-006 DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216439-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216439-002 DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216439-003 DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216439-004 DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216439-005 DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216439-006 DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216439-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216439-002 DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216439-003 DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216439-004 DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216439-005 DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216439-006 DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216439-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216439-002 DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216439-003 DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216439-004 DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2023-03-07 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 4 of 4 · 156 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Diltiazem Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DILTIAZEM HYDROCHLORIDE 180 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination OLH94387TE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 830874 Internal RxNorm lookup 830877 Internal RxNorm lookup 830879 Internal RxNorm lookup 830882 Internal RxNorm lookup 830897 Internal RxNorm lookup 830900 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70436-196-04 Diltiazem Hydrochloride 30 in 1 BOTTLE TABLET, EXTENDED RELEASE 30 9 70436-196-06 Diltiazem Hydrochloride 90 in 1 BOTTLE TABLET, EXTENDED RELEASE 90 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-196 DILTIAZEM HYDROCHLORIDE TABLET, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC] 6 Current NDC, 2 package rows 20240620_f7137458-0db3-7ecd-e053-6394a90a5f95.zip
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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70436-196-04 70436019604 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-196-04) 2023-03-20 No No Current 70436-196-06 70436019606 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-196-06) 2023-03-20 No No Current