Diltiazem Hydrochloride Extended-Release

Product NDC: 75907-046
Requested package NDC: 75907-046-01
11-digit product format: 759070046
Labeler code: 75907
Product ID: 75907-046_09bae4f6-ad9c-88db-a26b-3236e0f9022c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diltiazem Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Dr. Reddy's Labratories Inc.
Application: ANDA215775
Marketing category: ANDA
Marketing start: 2024-09-10
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: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215775-001	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05
A215775-002	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05
A215775-003	DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215775-001	AB1
A215775-002	AB1
A215775-003	AB1

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 3 · 93 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	A215775-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215775-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215775-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215775-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215775-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215775-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215775-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215775-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215775-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215775-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215775-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215775-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215775-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215775-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215775-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215775-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215775-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215775-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215775-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215775-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215775-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215775-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215775-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215775-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215775-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215775-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215775-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215775-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215775-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215775-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215775-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215775-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215775-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215775-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215775-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215775-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215775-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215775-002	DILTIAZEM HYDROCHLORIDE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215775-003	DILTIAZEM HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215775-001	DILTIAZEM HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2022-05-05	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 93 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	A215775-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215775-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215775-003	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215775-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215775-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215775-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215775-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215775-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215775-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215775-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215775-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215775-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215775-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215775-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215775-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215775-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215775-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215775-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215775-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215775-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215775-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215775-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215775-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215775-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215775-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215775-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215775-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215775-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215775-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215775-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215775-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215775-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215775-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215775-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215775-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215775-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215775-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215775-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215775-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215775-001	AB1	1	`301d65b070ca…`

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 Extended-Release
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DILTIAZEM HYDROCHLORIDE	120 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
830865	Internal RxNorm lookup
830869	Internal RxNorm lookup
830872	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f1d09c53-5eb9-0b7c-e977-e2a602e84e5f	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
75907-046-01	Diltiazem Hydrochloride Extended-Release	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75907-046-01	EA - Each	75907-046	49736264-9267-457a-aa68-04d20deca6c0	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75907-046	DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [DR. REDDY'S LABRATORIES INC.]	1	Current NDC, 1 package rows	20240910_f1d09c53-5eb9-0b7c-e977-e2a602e84e5f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	AvKARE	31e63a95-9e62-01c8-e063-6294a90af0e1	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215775 application number: ANDA215775
Diltiazem Hydrochloride Extended-Release	DILTIAZEM HYDROCHLORIDE	Dr. Reddy's Labratories Inc.	f1d09c53-5eb9-0b7c-e977-e2a602e84e5f	2024-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215775 application number: ANDA215775 ndc (package): 75907-046-01 ndc (product): 75907-046 ndc11 (package): 75907004601

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
830872	dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral Capsule	PSN	f1d09c53-5eb9-0b7c-e977-e2a602e84e5f	1
830872	dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral Capsule	PSN	31e63a95-9e62-01c8-e063-6294a90af0e1	1
830865	dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral Capsule	PSN	f1d09c53-5eb9-0b7c-e977-e2a602e84e5f	1
830865	dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral Capsule	PSN	31e63a95-9e62-01c8-e063-6294a90af0e1	1
830869	dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral Capsule	PSN	f1d09c53-5eb9-0b7c-e977-e2a602e84e5f	1
830869	dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral Capsule	PSN	31e63a95-9e62-01c8-e063-6294a90af0e1	1
830872	12 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule	SCD	f1d09c53-5eb9-0b7c-e977-e2a602e84e5f	1
830872	12 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule	SCD	31e63a95-9e62-01c8-e063-6294a90af0e1	1
830865	12 HR diltiazem hydrochloride 60 MG Extended Release Oral Capsule	SCD	f1d09c53-5eb9-0b7c-e977-e2a602e84e5f	1
830865	12 HR diltiazem hydrochloride 60 MG Extended Release Oral Capsule	SCD	31e63a95-9e62-01c8-e063-6294a90af0e1	1
830869	12 HR diltiazem hydrochloride 90 MG Extended Release Oral Capsule	SCD	31e63a95-9e62-01c8-e063-6294a90af0e1	1
830869	12 HR diltiazem hydrochloride 90 MG Extended Release Oral Capsule	SCD	f1d09c53-5eb9-0b7c-e977-e2a602e84e5f	1
830872	diltiazem hydrochloride 120 MG 12 HR Extended Release Oral Capsule	SY	f1d09c53-5eb9-0b7c-e977-e2a602e84e5f	1
830872	diltiazem hydrochloride 120 MG 12 HR Extended Release Oral Capsule	SY	31e63a95-9e62-01c8-e063-6294a90af0e1	1
830865	diltiazem hydrochloride 60 MG 12 HR Extended Release Oral Capsule	SY	31e63a95-9e62-01c8-e063-6294a90af0e1	1
830865	diltiazem hydrochloride 60 MG 12 HR Extended Release Oral Capsule	SY	f1d09c53-5eb9-0b7c-e977-e2a602e84e5f	1
830869	diltiazem hydrochloride 90 MG 12 HR Extended Release Oral Capsule	SY	f1d09c53-5eb9-0b7c-e977-e2a602e84e5f	1
830869	diltiazem hydrochloride 90 MG 12 HR Extended Release Oral Capsule	SY	31e63a95-9e62-01c8-e063-6294a90af0e1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
75907-046-01	75907004601	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (75907-046-01)	2024-09-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride Extended-Release Capsules, USP, Rx Only	AvKARE	2025-04-03	HUMAN PRESCRIPTION DRUG LABEL	1
Diltiazem Hydrochloride Extended-Release Capsules, USP, Rx Only	Dr. Reddy's Labratories Inc.	2024-08-19	HUMAN PRESCRIPTION DRUG LABEL	1