FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
63629-7981
11-digit product format
636297981
Labeler code
63629
Product ID
63629-7981_b2aa9386-ca59-470e-871f-df6c7f2a6869
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA020401
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-08-20
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
360 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

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-7981-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-7981-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-7981-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-7981-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-7981-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-7981-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-7981-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-7981-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-7981-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-7981-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-7981-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-7981-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-7981-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-7981-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-7981-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-7981-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-7981-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-7981-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-7981-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-7981-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-7981-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-7981-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63629-7981-28af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63629-7981-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7981-2834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7981-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7981-21332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7981-11332a3947898…d4bfe170f9cd…

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

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 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11c2088c7a36db…
2026-10-15 13:18:302026-09N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11c2088c7a36db…
2026-10-15 13:18:302026-09N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11c2088c7a36db…
2026-10-15 13:18:302026-09N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11c2088c7a36db…
2026-10-15 13:18:302026-09N020401-005TIAZAC360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11c2088c7a36db…
2026-10-15 13:18:302026-09N020401-006TIAZAC420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-16c2088c7a36db…
2026-09-14 22:38:342026-08N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1184e616aacf4f…
2026-09-14 22:38:342026-08N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1184e616aacf4f…
2026-09-14 22:38:342026-08N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1184e616aacf4f…
2026-09-14 22:38:342026-08N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1184e616aacf4f…
2026-09-14 22:38:342026-08N020401-005TIAZAC360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-1184e616aacf4f…
2026-09-14 22:38:342026-08N020401-006TIAZAC420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-1684e616aacf4f…
2026-08-18 06:07:402026-07N020401-001TIAZAC120MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07N020401-002TIAZAC180MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07N020401-003TIAZAC240MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07N020401-004TIAZAC300MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07N020401-005TIAZAC360MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD1995-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07N020401-006TIAZAC420MGCAPSULE, EXTENDED RELEASE / ORALAB4RLD, RS1998-10-16caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N020401-001AB41c2088c7a36db…
2026-10-15 13:18:302026-09N020401-002AB41c2088c7a36db…
2026-10-15 13:18:302026-09N020401-003AB41c2088c7a36db…
2026-10-15 13:18:302026-09N020401-004AB41c2088c7a36db…
2026-10-15 13:18:302026-09N020401-005AB41c2088c7a36db…
2026-10-15 13:18:302026-09N020401-006AB41c2088c7a36db…
2026-09-14 22:38:342026-08N020401-001AB4184e616aacf4f…
2026-09-14 22:38:342026-08N020401-002AB4184e616aacf4f…
2026-09-14 22:38:342026-08N020401-003AB4184e616aacf4f…
2026-09-14 22:38:342026-08N020401-004AB4184e616aacf4f…
2026-09-14 22:38:342026-08N020401-005AB4184e616aacf4f…
2026-09-14 22:38:342026-08N020401-006AB4184e616aacf4f…
2026-08-18 06:07:402026-07N020401-001AB41caaa826d4ba7…
2026-08-18 06:07:402026-07N020401-002AB41caaa826d4ba7…
2026-08-18 06:07:402026-07N020401-003AB41caaa826d4ba7…
2026-08-18 06:07:402026-07N020401-004AB41caaa826d4ba7…
2026-08-18 06:07:402026-07N020401-005AB41caaa826d4ba7…
2026-08-18 06:07:402026-07N020401-006AB41caaa826d4ba7…
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…

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
Brand name suffix
EXTENDED RELEASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE360 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
830795Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
58eeb8bc-91d0-4cf8-a0d7-be3548d92196Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-7981-12025-11-11Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only
63629-7981-12025-11-11Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only
63629-7981-22025-11-11Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only
63629-7981-22025-11-11Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only
63629-7981-12024-01-30Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only
63629-7981-12024-01-30Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only
63629-7981-22024-01-30Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only
63629-7981-22024-01-30Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7981-1Diltiazem HydrochlorideEXTENDED RELEASE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305
63629-7981-2Diltiazem HydrochlorideEXTENDED RELEASE90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7981-2EA - Each63629-79816508f0de-ff51-4900-9ce2-c1f150b10a4c12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7981DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 2 package rows20220203_58eeb8bc-91d0-4cf8-a0d7-be3548d92196.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-a0d1-2dd3f25cbf252026-08-07Warnings, 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
ndc (product): 63629-7981
Diltiazem Hydrochloride EXTENDED RELEASEDILTIAZEM HYDROCHLORIDEOceanside Pharmaceuticals862d65cb-a732-4786-b569-bad2eaafddfd2025-10-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 020401
application number: NDA020401
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
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSN58eeb8bc-91d0-4cf8-a0d7-be3548d921965
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCD58eeb8bc-91d0-4cf8-a0d7-be3548d921965
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSY58eeb8bc-91d0-4cf8-a0d7-be3548d921965

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7981-16362979810130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-7981-1) 2019-04-020000-00-00NoNoCurrent
63629-7981-26362979810290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-7981-2) 2022-02-020000-00-00NoNoCurrent