Home NDC 71335-9719-3 TIADYLT ER
Product NDC 71335-9719
Requested package NDC 71335-9719-3
11-digit product format 713359719
Labeler code 71335
Product ID 71335-9719_377c5eca-9482-002a-e063-6294a90a9454
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diltiazem hydrochloride
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA206641
Marketing category ANDA
Marketing start 2017-11-08
Substance DILTIAZEM HYDROCHLORIDE
Active strength 120 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 A206641-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 A206641-002 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 A206641-003 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 A206641-004 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 A206641-005 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 A206641-006 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 420MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11
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 7 · 264 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 A206641-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206641-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206641-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206641-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206641-005 DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206641-006 DILTIAZEM HYDROCHLORIDE 420MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 A206641-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206641-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206641-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206641-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206641-005 DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206641-006 DILTIAZEM HYDROCHLORIDE 420MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206641-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206641-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206641-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206641-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206641-005 DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206641-006 DILTIAZEM HYDROCHLORIDE 420MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206641-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206641-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206641-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206641-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206641-005 DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206641-006 DILTIAZEM HYDROCHLORIDE 420MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206641-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206641-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206641-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206641-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206641-005 DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206641-006 DILTIAZEM HYDROCHLORIDE 420MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206641-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206641-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206641-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206641-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206641-005 DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206641-006 DILTIAZEM HYDROCHLORIDE 420MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206641-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206641-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206641-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206641-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL AB4 2017-08-11 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 264 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 TIADYLT ER
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DILTIAZEM HYDROCHLORIDE 120 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 830861 Internal RxNorm lookup 1988308 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 71335-9719-1 TIADYLT ER 30 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 30 103 71335-9719-2 TIADYLT ER 28 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 28 103 71335-9719-3 TIADYLT ER 90 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 90 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-9719 TIADYLT ER (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK] 101 Current NDC, 3 package rows 20240410_b4b4e53e-fc99-4f34-abc2-57e4f28aff84.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 · 3 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 71335-9719-3 71335971903 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9719-3) 2025-06-12 No No Current