CARTIA XT

Product NDC: 72189-344
11-digit product format: 721890344
Labeler code: 72189
Product ID: 72189-344_2c4c7b35-cdc7-a9c1-e063-6394a90a7634
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diltiazem hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: DirectRx
Application: ANDA074752
Marketing category: ANDA
Marketing start: 2022-04-06
Substance: DILTIAZEM HYDROCHLORIDE
Active strength: 300 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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-344-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-344-90	`0efc9e666f02…`	`f202fb6c5f17…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A074752-001	CARTIA XT	DILTIAZEM HYDROCHLORIDE	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09
A074752-002	CARTIA XT	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09
A074752-003	CARTIA XT	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09
A074752-004	CARTIA XT	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-001	CARTIA XT	180MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-002	CARTIA XT	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-003	CARTIA XT	240MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-004	CARTIA XT	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	1998-07-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A074752-001	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074752-002	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074752-003	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074752-004	AB3	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074752-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074752-002	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074752-003	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074752-004	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074752-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074752-002	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074752-003	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074752-004	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-002	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-003	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074752-004	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074752-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074752-002	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074752-003	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074752-004	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074752-004	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074752-004	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-002	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-003	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074752-004	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-002	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-003	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074752-004	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-002	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-003	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074752-004	AB3	1	`5bbf6a4d5a75…`

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: CARTIA XT
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DILTIAZEM HYDROCHLORIDE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
OLH94387TE	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
dbfda3a5-5602-6e47-e053-2995a90ac07b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
61ebbccf-eedf-453b-940e-dba67b7a5fef	Product name	4	20260107
a8d6eaa3-afcc-47e5-be12-0c9251fc8740	Product name	1	20251124
f6700316-a6ba-5e59-3413-8ede05ae58b9	Product name	7	20250625
8615f7a1-1e8f-8281-8601-d7a637926d1f	Product name	4	20250522
3a9daa2f-bcd1-13de-a1b4-6172caa7f308	Product name	2	20240419
f7129636-cba8-86c2-8bfb-9e2e2a9c7628	Product name	2	20240314
378290be-e30f-0e68-1201-165e93c337e8	Product name	3	20231212
c733b56e-b0b5-4495-9857-0256a8242279	Product name	1	20220520
f4df4721-60d9-7fd2-a665-5c3c9f55af81	Product name	2	20171003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-344-90	CARTIA XT	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-344-90	EA - Each	72189-344	8731f899-0044-4637-a42a-c2780b7ec130	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-344	CARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [DIRECTRX]	3	Current NDC, Legacy NDC, 1 package rows	20250123_dbfda3a5-5602-6e47-e053-2995a90ac07b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cartia XT	DILTIAZEM HYDROCHLORIDE	Actavis Pharma, Inc.	2dc2b889-8443-4f7f-83be-86c68e179804	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074752 application number: ANDA074752
Cartia XT	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	de671934-25a8-4df6-b7a1-97e0337e9e2b	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074752 application number: ANDA074752
Cartia XT	DILTIAZEM HYDROCHLORIDE	Bryant Ranch Prepack	e02f5fad-6482-4d5d-91c5-0ae6b0ce15b8	2025-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074752 application number: ANDA074752
CARTIA XT	DILTIAZEM HYDROCHLORIDE	DirectRx	dbfda3a5-5602-6e47-e053-2995a90ac07b	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074752 application number: ANDA074752 ndc (product): 72189-344

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OLH94387TE	DILTIAZEM HYDROCHLORIDE	33286-22-5	DILTIAZEM HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-344-90	72189034490	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-344-90)	2022-04-06	0000-00-00	No	No	Current