Diltiazem Hydrochloride

Product NDC
71335-2739
11-digit product format
713352739
Labeler code
71335
Product ID
71335-2739_cf3a02fa-c4e4-44e2-bf35-7a5172e4bc01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205231
Marketing category
ANDA
Marketing start
2018-10-01
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
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205231-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30
A205231-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30
A205231-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30
A205231-004DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30
A205231-005DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A205231-001AB3
A205231-002AB3
A205231-003AB3
A205231-004AB3
A205231-005AB3

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-305bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205231-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-002AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-003AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-004AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205231-005AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-002AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-003AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-004AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205231-005AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205231-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-002AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-003AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-004AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205231-005AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-002AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-003AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-004AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205231-005AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-002AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-003AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-004AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205231-005AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-002AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-003AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-004AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205231-005AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-002AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-003AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-004AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205231-005AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205231-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205231-002AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205231-003AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205231-004AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205231-005AB315bbf6a4d5a75…

Additional Listing Data#

Finished product
Yes
Brand name base
Diltiazem Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE180 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c8809dc9-b99b-4d30-a7da-0bc21aa90f9cAvailable 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
71335-2739-1Diltiazem Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
71335-2739-2Diltiazem Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEMajor Pharmaceuticalse7476adc-a940-4e76-a1dd-c418de493bc02026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutions465dbab3-f201-4441-8f55-92a843b5134f2026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEGolden State Medical Supply, Inc.c9f17187-e958-106b-e053-2a95a90a54d82026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDECardinal Health 107, LLCbdb9e7cf-bfbb-48b4-a8be-9038820d82792026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEUpsher-Smith Laboratories, LLCbb32d681-9a83-431e-9984-a5cee2c948522026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutions839af3af-4040-4cf4-8d4a-881a053514cc2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack22e653e5-4122-4d7d-b9ad-0bdc1390fb402025-10-20Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc8809dc9-b99b-4d30-a7da-0bc21aa90f9c2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231
ndc (product): 71335-2739
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutionsf317de31-495c-4268-8171-89534bf1dd362024-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSNc8809dc9-b99b-4d30-a7da-0bc21aa90f9c1
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCDc8809dc9-b99b-4d30-a7da-0bc21aa90f9c1
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSYc8809dc9-b99b-4d30-a7da-0bc21aa90f9c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2739-17133527390130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2739-1) 2025-10-02NoNoCurrent
71335-2739-27133527390290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2739-2) 2025-10-02NoNoCurrent