Diltiazem Hydrochloride

Product NDC
48433-031
Requested package NDC
48433-031-20
11-digit product format
484330031
Labeler code
48433
Product ID
48433-031_49eef6c8-e1fc-86af-e063-6294a90a0309
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Safecor Health LLC
Application
ANDA074910
Marketing category
ANDA
Marketing start
2026-02-02
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 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
A074910-001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-02
A074910-002DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-02
A074910-003DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB1RS1997-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074910-001AB1
A074910-002AB1
A074910-003AB1

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 UTC2026-02A074910-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074910-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074910-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB1RS1997-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074910-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074910-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074910-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB1RS1997-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A074910-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074910-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074910-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB1RS1997-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074910-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074910-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074910-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB1RS1997-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074910-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074910-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074910-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB1RS1997-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074910-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074910-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074910-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB1RS1997-05-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074910-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074910-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074910-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB1RS1997-05-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074910-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074910-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074910-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB1RS1997-05-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074910-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074910-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074910-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB1RS1997-05-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074910-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A074910-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A074910-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB1RS1997-05-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074910-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074910-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074910-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB1RS1997-05-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074910-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074910-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074910-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB1RS1997-05-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074910-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074910-002DILTIAZEM HYDROCHLORIDE90MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074910-003DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB1RS1997-05-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074910-001DILTIAZEM HYDROCHLORIDE60MGCAPSULE, EXTENDED RELEASE / ORALAB11997-05-028072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 109 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074910-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074910-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074910-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074910-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074910-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074910-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074910-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074910-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074910-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074910-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074910-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074910-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074910-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074910-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074910-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074910-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074910-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074910-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074910-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074910-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074910-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074910-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074910-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074910-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074910-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074910-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074910-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074910-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A074910-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A074910-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074910-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074910-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074910-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074910-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074910-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074910-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074910-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074910-002AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074910-003AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074910-001AB118072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Diltiazem Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE90 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
830865Internal RxNorm lookup
830869Internal RxNorm lookup
830872Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc02db0f-5311-4b61-896e-bfe340832735Available 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
48433-031-01Diltiazem Hydrochloride1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE12
48433-031-20Diltiazem Hydrochloride100 in 1 CARTONCAPSULE, EXTENDED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-031-20EA - Each48433-03182130032-c1c7-463a-8813-2fa31848de9112026-05-22

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDESafecor Health LLCfc02db0f-5311-4b61-896e-bfe3408327352026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074910
application number: ANDA074910
ndc (package): 48433-031-20
ndc (product): 48433-031
ndc11 (package): 48433003120
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEMylan Pharmaceuticals Inc.ec7e93b8-666c-4d2f-8d08-07931e09f7482025-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074910
application number: ANDA074910
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEMylan Institutional Inc.9942f1a2-f66d-4d9e-9794-49bee8abf5ab2025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074910
application number: ANDA074910
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDECoupler LLC2ced821f-19a6-4c7e-e063-6394a90adb802025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074910
application number: ANDA074910

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830872dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral CapsulePSNfc02db0f-5311-4b61-896e-bfe3408327352
830865dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral CapsulePSNfc02db0f-5311-4b61-896e-bfe3408327352
830869dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral CapsulePSNfc02db0f-5311-4b61-896e-bfe3408327352
83087212 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDfc02db0f-5311-4b61-896e-bfe3408327352
83086512 HR diltiazem hydrochloride 60 MG Extended Release Oral CapsuleSCDfc02db0f-5311-4b61-896e-bfe3408327352
83086912 HR diltiazem hydrochloride 90 MG Extended Release Oral CapsuleSCDfc02db0f-5311-4b61-896e-bfe3408327352
830872diltiazem hydrochloride 120 MG 12 HR Extended Release Oral CapsuleSYfc02db0f-5311-4b61-896e-bfe3408327352
830865diltiazem hydrochloride 60 MG 12 HR Extended Release Oral CapsuleSYfc02db0f-5311-4b61-896e-bfe3408327352
830869diltiazem hydrochloride 90 MG 12 HR Extended Release Oral CapsuleSYfc02db0f-5311-4b61-896e-bfe3408327352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48433-031-2048433003120100 BLISTER PACK in 1 CARTON (48433-031-20) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (48433-031-01) 100 blister pack2026-02-02NoNoCurrent