Diltiazem Hydrochloride

Product NDC
70518-2789
Requested package NDC
70518-2789-0
11-digit product format
705182789
Labeler code
70518
Product ID
70518-2789_5e44f2f6-e210-81ad-e063-6294a90a26db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA205231
Marketing category
ANDA
Marketing start
2020-06-17
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
120 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30c2088c7a36db…
2026-10-15 13:18:302026-09A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30c2088c7a36db…
2026-10-15 13:18:302026-09A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30c2088c7a36db…
2026-10-15 13:18:302026-09A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30c2088c7a36db…
2026-10-15 13:18:302026-09A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30c2088c7a36db…
2026-09-14 22:38:342026-08A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3084e616aacf4f…
2026-09-14 22:38:342026-08A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3084e616aacf4f…
2026-09-14 22:38:342026-08A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3084e616aacf4f…
2026-09-14 22:38:342026-08A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3084e616aacf4f…
2026-09-14 22:38:342026-08A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-3084e616aacf4f…
2026-08-18 06:07:402026-07A205231-001DILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-002DILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-003DILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-004DILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-005DILTIAZEM HYDROCHLORIDE360MGCAPSULE, EXTENDED RELEASE / ORALAB32018-08-30caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A205231-001AB31c2088c7a36db…
2026-10-15 13:18:302026-09A205231-002AB31c2088c7a36db…
2026-10-15 13:18:302026-09A205231-003AB31c2088c7a36db…
2026-10-15 13:18:302026-09A205231-004AB31c2088c7a36db…
2026-10-15 13:18:302026-09A205231-005AB31c2088c7a36db…
2026-09-14 22:38:342026-08A205231-001AB3184e616aacf4f…
2026-09-14 22:38:342026-08A205231-002AB3184e616aacf4f…
2026-09-14 22:38:342026-08A205231-003AB3184e616aacf4f…
2026-09-14 22:38:342026-08A205231-004AB3184e616aacf4f…
2026-09-14 22:38:342026-08A205231-005AB3184e616aacf4f…
2026-08-18 06:07:402026-07A205231-001AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-002AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-003AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-004AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A205231-005AB31caaa826d4ba7…
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…

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
IngredientStrength
DILTIAZEM HYDROCHLORIDE120 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
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
de304c9f-000b-4ac1-b812-a0f3a3e3df1aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-02-02Diltiazem ER CapsulesRx only
2022-02-02Diltiazem ER CapsulesRx only
2022-01-28Diltiazem ER CapsulesRx only
2022-01-28Diltiazem ER CapsulesRx only

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
Diltiazem HydrochlorideDILTIAZEM HYDROCHLORIDEA-S Medication Solutionsf317de31-495c-4268-8171-89534bf1dd362024-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205231
application number: ANDA205231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2789-07051827890030 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2789-0) 2020-06-170000-00-00NoNoCurrent