DILTIAZEM HYDROCHLORIDE

Product NDC
16714-525
11-digit product format
167140525
Labeler code
16714
Product ID
16714-525_174fcbb5-73f2-9d6d-8d3b-74f7ed2615f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DILTIAZEM HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
NORTHSTAR RX LLC
Application
ANDA074943
Marketing category
ANDA
Marketing start
2022-02-22
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
240 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074943-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB2RS1998-08-06
A074943-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-19
A074943-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A074943-001AB2
A074943-002AB2
A074943-003AB2

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074943-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB2RS1998-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074943-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074943-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074943-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB2RS1998-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074943-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074943-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074943-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB2RS1998-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074943-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074943-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074943-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB2RS1998-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074943-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074943-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074943-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB2RS1998-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074943-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074943-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074943-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB2RS1998-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074943-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074943-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074943-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB2RS1998-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074943-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074943-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074943-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB2RS1998-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074943-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074943-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074943-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB2RS1998-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074943-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074943-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074943-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB2RS1998-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A074943-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A074943-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074943-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB2RS1998-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074943-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074943-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074943-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB2RS1998-08-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074943-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074943-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074943-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB2RS1998-08-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074943-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074943-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB22000-12-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074943-001DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB2RS1998-08-068072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074943-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074943-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074943-003AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074943-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074943-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074943-003AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074943-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074943-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074943-003AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074943-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074943-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074943-003AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074943-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074943-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074943-003AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074943-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074943-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074943-003AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074943-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074943-002AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074943-003AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074943-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074943-002AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074943-003AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074943-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074943-002AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074943-003AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074943-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A074943-002AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A074943-003AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074943-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074943-002AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074943-003AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074943-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074943-002AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074943-003AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074943-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074943-002AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074943-003AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074943-001AB218072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
DILTIAZEM HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE240 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
OLH94387TEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
830837Internal RxNorm lookup
830845Internal RxNorm lookup
830861Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
56616fc9-f3f7-8e0a-22c8-a6af106e6b1dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
61ebbccf-eedf-453b-940e-dba67b7a5fefProduct name420260107
a8d6eaa3-afcc-47e5-be12-0c9251fc8740Product name120251124
f6700316-a6ba-5e59-3413-8ede05ae58b9Product name720250625
8615f7a1-1e8f-8281-8601-d7a637926d1fProduct name420250522
3a9daa2f-bcd1-13de-a1b4-6172caa7f308Product name220240419
f7129636-cba8-86c2-8bfb-9e2e2a9c7628Product name220240314
378290be-e30f-0e68-1201-165e93c337e8Product name320231212
c733b56e-b0b5-4495-9857-0256a8242279Product name120220520
f4df4721-60d9-7fd2-a665-5c3c9f55af81Product name220171003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-525-01DILTIAZEM HYDROCHLORIDE100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1004
16714-525-02DILTIAZEM HYDROCHLORIDE500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-525-01EA - Each16714-5253b85a8a2-49e4-4087-9efe-bc913031ec9a12022-04-06
16714-525-02EA - Each16714-525c9879912-a018-4242-a08e-44f05fb917b112022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-525DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTHSTAR RX LLC]3Current NDC, Legacy NDC, 2 package rows20240926_56616fc9-f3f7-8e0a-22c8-a6af106e6b1d.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack3a620125-898a-47ba-9000-4295c3a3ad722025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074943
application number: ANDA074943
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDENORTHSTAR RX LLC56616fc9-f3f7-8e0a-22c8-a6af106e6b1d2025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074943
application number: ANDA074943
ndc (product): 16714-525
DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEApotex Corp.56573e9d-7bd2-694c-cd6d-26039590e5482025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074943
application number: ANDA074943

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY56616fc9-f3f7-8e0a-22c8-a6af106e6b1d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-525-0116714052501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-525-01) 2022-02-220000-00-00NoNoCurrent
16714-525-0216714052502500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-525-02) 2022-02-220000-00-00NoNoCurrent