Home NDC 27808-323 Diltiazem Hydrochloride
Product NDC 27808-323
11-digit product format 278080323
Labeler code 27808
Product ID 27808-323_dda96cd7-5d7c-4451-97d6-fe633b98933f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diltiazem Hydrochloride
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Cranbury Pharmaceuticals, LLC
Application ANDA219073
Marketing category ANDA
Marketing start 2026-10-01
Substance DILTIAZEM HYDROCHLORIDE
Active strength 90 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219073-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 A219073-002 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 A219073-003 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
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 A219073-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219073-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219073-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 A219073-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219073-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219073-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219073-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219073-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219073-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219073-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219073-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219073-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219073-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219073-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219073-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219073-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219073-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219073-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219073-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219073-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219073-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-03-24 a50c72e98297…
Observed Orange Book normalized TE history# 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 90 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 27808-323-01 27808032301 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27808-323-01) 2026-10-01 No No Current