Cartia

Product NDC
70518-1537
11-digit product format
705181537
Labeler code
70518
Product ID
70518-1537_b8e30173-e52d-0cc8-e053-2995a90af8af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA074752
Marketing category
ANDA
Marketing start
2018-10-15
Marketing end
0000-00-00
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-1537DDiscontinued by firm2026-10-05
excluded packagepackage70518-153770518-1537-0DDiscontinued by firm2026-10-05

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-1537-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-1537-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-1537-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-1537-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-1537-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-1537-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-1537-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-1537-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-1537-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-1537-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-1537-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-1537-0557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074752-001CARTIA XTDILTIAZEM HYDROCHLORIDE180MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09
A074752-002CARTIA XTDILTIAZEM HYDROCHLORIDE120MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09
A074752-003CARTIA XTDILTIAZEM HYDROCHLORIDE240MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09
A074752-004CARTIA XTDILTIAZEM HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A074752-001AB3
A074752-002AB3
A074752-003AB3
A074752-004AB3

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074752-001CARTIA XT180MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-0984e616aacf4f…
2026-09-14 22:38:342026-08A074752-002CARTIA XT120MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-0984e616aacf4f…
2026-09-14 22:38:342026-08A074752-003CARTIA XT240MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-0984e616aacf4f…
2026-09-14 22:38:342026-08A074752-004CARTIA XT300MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-0984e616aacf4f…
2026-08-18 06:07:402026-07A074752-001CARTIA XT180MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07A074752-002CARTIA XT120MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07A074752-003CARTIA XT240MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07A074752-004CARTIA XT300MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074752-001CARTIA XT180MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074752-002CARTIA XT120MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074752-003CARTIA XT240MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074752-004CARTIA XT300MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074752-001CARTIA XT180MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074752-002CARTIA XT120MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074752-003CARTIA XT240MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074752-004CARTIA XT300MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074752-001CARTIA XT180MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074752-002CARTIA XT120MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074752-003CARTIA XT240MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074752-004CARTIA XT300MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074752-001CARTIA XT180MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074752-002CARTIA XT120MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074752-003CARTIA XT240MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074752-004CARTIA XT300MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074752-001CARTIA XT180MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074752-002CARTIA XT120MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074752-003CARTIA XT240MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074752-004CARTIA XT300MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074752-001CARTIA XT180MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074752-002CARTIA XT120MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074752-003CARTIA XT240MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074752-004CARTIA XT300MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074752-001CARTIA XT180MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074752-002CARTIA XT120MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074752-003CARTIA XT240MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074752-004CARTIA XT300MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074752-001CARTIA XT180MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074752-002CARTIA XT120MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074752-003CARTIA XT240MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074752-004CARTIA XT300MGCAPSULE, EXTENDED RELEASE / ORALAB31998-07-095bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A074752-001AB3184e616aacf4f…
2026-09-14 22:38:342026-08A074752-002AB3184e616aacf4f…
2026-09-14 22:38:342026-08A074752-003AB3184e616aacf4f…
2026-09-14 22:38:342026-08A074752-004AB3184e616aacf4f…
2026-08-18 06:07:402026-07A074752-001AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A074752-002AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A074752-003AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A074752-004AB31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074752-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074752-002AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074752-003AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074752-004AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074752-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074752-002AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074752-003AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074752-004AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074752-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074752-002AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074752-003AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074752-004AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074752-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074752-002AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074752-003AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074752-004AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074752-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074752-002AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074752-003AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074752-004AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074752-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074752-002AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074752-003AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074752-004AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074752-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074752-002AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074752-003AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074752-004AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074752-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074752-002AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074752-003AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074752-004AB315bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
Cartia XTDILTIAZEM HYDROCHLORIDEActavis Pharma, Inc.2dc2b889-8443-4f7f-83be-86c68e1798042026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074752
application number: ANDA074752
Cartia XTDILTIAZEM HYDROCHLORIDEBryant Ranch Prepackde671934-25a8-4df6-b7a1-97e0337e9e2b2025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074752
application number: ANDA074752
Cartia XTDILTIAZEM HYDROCHLORIDEBryant Ranch Prepacke02f5fad-6482-4d5d-91c5-0ae6b0ce15b82025-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074752
application number: ANDA074752
CARTIA XTDILTIAZEM HYDROCHLORIDEDirectRxdbfda3a5-5602-6e47-e053-2995a90ac07b2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074752
application number: ANDA074752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1537-07051815370030 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-1537-0) 2018-10-150000-00-00NoNoCurrent