FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
68682-368
11-digit product format
686820368
Labeler code
68682
Product ID
68682-368_f51e2ce0-22dd-4a31-bab8-70b0b55864af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
NDA020401
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-08-20
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
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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020401-001TIAZACDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11
N020401-002TIAZACDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11
N020401-003TIAZACDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11
N020401-004TIAZACDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11
N020401-005TIAZACDILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11
N020401-006TIAZACDILTIAZEM HYDROCHLORIDE420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
N020401-001AB4
N020401-002AB4
N020401-003AB4
N020401-004AB4
N020401-005AB4
N020401-006AB4

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 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-005TIAZAC360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-006TIAZAC420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-005TIAZAC360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-006TIAZAC420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-005TIAZAC360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-006TIAZAC420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-005TIAZAC360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-006TIAZAC420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-005TIAZAC360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-006TIAZAC420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-005TIAZAC360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-006TIAZAC420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-112680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020401-001AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-002AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-003AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-004AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-005AB41011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020401-006AB41011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-001AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-002AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-003AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-004AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-005AB4131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020401-006AB4131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020401-001AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-002AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-003AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-004AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-005AB416a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020401-006AB416a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-001AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-002AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-003AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-004AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-005AB41fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020401-006AB41fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-001AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-002AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-003AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-004AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-005AB41b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020401-006AB41b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-001AB4103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-002AB4103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-003AB4103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-004AB4103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-005AB4103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020401-006AB4103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-001AB412680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-002AB412680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-003AB412680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020401-004AB412680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Diltiazem Hydrochloride
Brand name suffix
EXTENDED RELEASE
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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
830795Internal RxNorm lookup
830801Internal RxNorm lookup
830837Internal RxNorm lookup
830845Internal RxNorm lookup
830861Internal RxNorm lookup
831359Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
862d65cb-a732-4786-b569-bad2eaafddfdAvailable 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
68682-368-90Diltiazem HydrochlorideEXTENDED RELEASE90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-368-90EA - Each68682-36832b9c335-c373-4d6e-b563-d25b81cd572912014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diltiazem hydrochlorideACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
DiltiazemACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1; 750000 MW)INACTIVE INGREDIENTP2OM2Q86BIDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
FD&C Green No. 3INACTIVE INGREDIENT3P3ONR6O1SDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
gelatinINACTIVE INGREDIENT2G86QN327LDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WODILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
magnesium stearateINACTIVE INGREDIENT70097M6I30DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
sucrose stearateINACTIVE INGREDIENT274KW0O50MDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
talcINACTIVE INGREDIENT7SEV7J4R1UDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-368DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]7Current NDC, Legacy NDC, 1 package rows20201204_862d65cb-a732-4786-b569-bad2eaafddfd.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIAZAC EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEBausch Health US, LLCc567fe7e-887e-4291-a0d1-2dd3f25cbf252025-11-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 020401
application number: NDA020401
Diltiazem Hydrochloride EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEBryant Ranch Prepack58eeb8bc-91d0-4cf8-a0d7-be3548d921962025-11-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 020401
application number: NDA020401
Diltiazem Hydrochloride EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEOceanside Pharmaceuticals862d65cb-a732-4786-b569-bad2eaafddfd2025-10-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 020401
application number: NDA020401
ndc (product): 68682-368
Diltiazem Hydrochloride EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackc7c6a74e-5f73-4265-a0e0-8fd2cd26909e2025-01-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 020401
application number: NDA020401
DILTIAZEM HYDROCHLORIDE EXTENDED RELEASEDILTIAZEM HYDROCHLORIDE EXTENDED RELEASEdirect rxc7cf9276-4b4c-10b2-e053-2995a90a37382025-01-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 020401
application number: NDA020401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN862d65cb-a732-4786-b569-bad2eaafddfd10
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN862d65cb-a732-4786-b569-bad2eaafddfd10
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN862d65cb-a732-4786-b569-bad2eaafddfd10
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSN862d65cb-a732-4786-b569-bad2eaafddfd10
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSN862d65cb-a732-4786-b569-bad2eaafddfd10
831359dilTIAZem hydrochloride 420 MG 24HR Extended Release Oral CapsulePSN862d65cb-a732-4786-b569-bad2eaafddfd10
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD862d65cb-a732-4786-b569-bad2eaafddfd10
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD862d65cb-a732-4786-b569-bad2eaafddfd10
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD862d65cb-a732-4786-b569-bad2eaafddfd10
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCD862d65cb-a732-4786-b569-bad2eaafddfd10
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCD862d65cb-a732-4786-b569-bad2eaafddfd10
83135924 HR diltiazem hydrochloride 420 MG Extended Release Oral CapsuleSCD862d65cb-a732-4786-b569-bad2eaafddfd10
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY862d65cb-a732-4786-b569-bad2eaafddfd10
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY862d65cb-a732-4786-b569-bad2eaafddfd10
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY862d65cb-a732-4786-b569-bad2eaafddfd10
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSY862d65cb-a732-4786-b569-bad2eaafddfd10
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSY862d65cb-a732-4786-b569-bad2eaafddfd10
831359diltiazem hydrochloride 420 MG 24 HR Extended Release Oral CapsuleSY862d65cb-a732-4786-b569-bad2eaafddfd10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-368-906868203689090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68682-368-90) 2014-08-200000-00-00NoNoCurrent