Diltiazem Hydrochloride

Product NDC: 68682-708
11-digit product format: 686820708
Labeler code: 68682
Product ID: 68682-708_9c3468f2-1199-4180-9e57-089b5353251a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diltiazem Hydrochloride Extended-Release Tablets
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Oceanside Pharmaceuticals
Application: NDA021392
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-02-06
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021392-001	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06
N021392-002	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06
N021392-003	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06
N021392-004	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06
N021392-005	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06
N021392-006	CARDIZEM LA	DILTIAZEM HYDROCHLORIDE	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N021392-001	AB
N021392-002	AB
N021392-003	AB
N021392-004	AB
N021392-005	AB
N021392-006	AB

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 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021392-001	CARDIZEM LA	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-002	CARDIZEM LA	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-003	CARDIZEM LA	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-004	CARDIZEM LA	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-005	CARDIZEM LA	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-006	CARDIZEM LA	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-001	CARDIZEM LA	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-002	CARDIZEM LA	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-003	CARDIZEM LA	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-004	CARDIZEM LA	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-005	CARDIZEM LA	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-006	CARDIZEM LA	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021392-001	CARDIZEM LA	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-002	CARDIZEM LA	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-003	CARDIZEM LA	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-004	CARDIZEM LA	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-005	CARDIZEM LA	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-006	CARDIZEM LA	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-001	CARDIZEM LA	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-002	CARDIZEM LA	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-003	CARDIZEM LA	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-004	CARDIZEM LA	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-005	CARDIZEM LA	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-006	CARDIZEM LA	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-001	CARDIZEM LA	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-002	CARDIZEM LA	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-003	CARDIZEM LA	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-004	CARDIZEM LA	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-005	CARDIZEM LA	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-006	CARDIZEM LA	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-001	CARDIZEM LA	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-002	CARDIZEM LA	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-003	CARDIZEM LA	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-004	CARDIZEM LA	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-005	CARDIZEM LA	360MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-006	CARDIZEM LA	420MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2003-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021392-001	CARDIZEM LA	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021392-002	CARDIZEM LA	180MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021392-003	CARDIZEM LA	240MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021392-004	CARDIZEM LA	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2003-02-06	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021392-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021392-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021392-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021392-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021392-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021392-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021392-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021392-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021392-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021392-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021392-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021392-004	AB	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021392-001	7108866	2019-12-17	U-107	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-001	6923984	2021-02-25		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-002	7108866	2019-12-17	U-107	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-002	6923984	2021-02-25		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-003	7108866	2019-12-17	U-107	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-003	6923984	2021-02-25		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-004	7108866	2019-12-17	U-107	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-004	6923984	2021-02-25		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-005	7108866	2019-12-17	U-107	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-005	6923984	2021-02-25		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-006	7108866	2019-12-17	U-107	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021392-006	6923984	2021-02-25		Drug product	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021392-001	6923984	2021-02-25		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021392-002	6923984	2021-02-25		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021392-003	6923984	2021-02-25		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021392-004	6923984	2021-02-25		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021392-005	6923984	2021-02-25		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021392-006	6923984	2021-02-25		Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021392-001	6923984	2021-02-25		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021392-002	6923984	2021-02-25		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021392-003	6923984	2021-02-25		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021392-004	6923984	2021-02-25		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021392-005	6923984	2021-02-25		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021392-006	6923984	2021-02-25		Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021392-001	6923984	2021-02-25		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021392-002	6923984	2021-02-25		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021392-003	6923984	2021-02-25		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021392-004	6923984	2021-02-25		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021392-005	6923984	2021-02-25		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021392-006	6923984	2021-02-25		Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021392-001	6923984	2021-02-25		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021392-002	6923984	2021-02-25		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021392-003	6923984	2021-02-25		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021392-004	6923984	2021-02-25		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021392-005	6923984	2021-02-25		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021392-006	6923984	2021-02-25		Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021392-001	6923984	2021-02-25		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021392-002	6923984	2021-02-25		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021392-003	6923984	2021-02-25		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021392-004	6923984	2021-02-25		Drug product	`c0c555d07b60…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Cardizem LA	DILTIAZEM HYDROCHLORIDE	Bausch Health US LLC	3e180dc7-c871-4efc-8755-cae882976c8d	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021392 application number: NDA021392
Diltiazem Hydrochloride	DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS	Oceanside Pharmaceuticals	73b3607a-99d0-44d8-92ef-0074684c9d7d	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021392 application number: NDA021392 ndc (product): 68682-708

Additional Listing Data#

Finished product: Yes
Brand name base: Diltiazem Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DILTIAZEM HYDROCHLORIDE	360 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
830874	Internal RxNorm lookup
830877	Internal RxNorm lookup
830879	Internal RxNorm lookup
830882	Internal RxNorm lookup
830897	Internal RxNorm lookup
830900	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
73b3607a-99d0-44d8-92ef-0074684c9d7d	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
68682-708-30	Diltiazem Hydrochloride	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		10
68682-708-90	Diltiazem Hydrochloride	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68682-708-30	EA - Each	68682-708	ea281a67-5316-4034-b5de-5f5a06da8121	1	2014-04-03
68682-708-90	EA - Each	68682-708	626e1331-a2b6-47d5-a840-02b8743dfc3d	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diltiazem Hydrochloride	ACTIVE INGREDIENT	OLH94387TE	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
Diltiazem	ACTIVE MOIETY	EE92BBP03H	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
ethyl acrylate and methyl methacrylate copolymer (2:1; 750000 mw)	INACTIVE INGREDIENT	P2OM2Q86BI	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
microcrystalline wax	INACTIVE INGREDIENT	XOF597Q3KY	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
sucrose stearate	INACTIVE INGREDIENT	274KW0O50M	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-708	DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 2 package rows	20230331_73b3607a-99d0-44d8-92ef-0074684c9d7d.zip

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
830874	dilTIAZem hydrochloride 120 MG 24HR Extended Release Oral Tablet	PSN	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830877	dilTIAZem hydrochloride 180 MG 24HR Extended Release Oral Tablet	PSN	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830879	dilTIAZem hydrochloride 240 MG 24HR Extended Release Oral Tablet	PSN	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830882	dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral Tablet	PSN	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830897	dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral Tablet	PSN	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830900	dilTIAZem hydrochloride 420 MG 24HR Extended Release Oral Tablet	PSN	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830874	24 HR diltiazem hydrochloride 120 MG Extended Release Oral Tablet	SCD	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830877	24 HR diltiazem hydrochloride 180 MG Extended Release Oral Tablet	SCD	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830879	24 HR diltiazem hydrochloride 240 MG Extended Release Oral Tablet	SCD	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830882	24 HR diltiazem hydrochloride 300 MG Extended Release Oral Tablet	SCD	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830897	24 HR diltiazem hydrochloride 360 MG Extended Release Oral Tablet	SCD	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830900	24 HR diltiazem hydrochloride 420 MG Extended Release Oral Tablet	SCD	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830874	diltiazem hydrochloride 120 MG 24 HR Extended Release Oral Tablet	SY	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830877	diltiazem hydrochloride 180 MG 24 HR Extended Release Oral Tablet	SY	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830879	diltiazem hydrochloride 240 MG 24 HR Extended Release Oral Tablet	SY	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830882	diltiazem hydrochloride 300 MG 24 HR Extended Release Oral Tablet	SY	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830897	diltiazem hydrochloride 360 MG 24 HR Extended Release Oral Tablet	SY	73b3607a-99d0-44d8-92ef-0074684c9d7d	10
830900	diltiazem hydrochloride 420 MG 24 HR Extended Release Oral Tablet	SY	73b3607a-99d0-44d8-92ef-0074684c9d7d	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-708-30	68682070830	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-708-30)	2014-02-06	0000-00-00	No	No	Current
68682-708-90	68682070890	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-708-90)	2014-02-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diltiazem Hydrochloride Extended-Release Tablets	Oceanside Pharmaceuticals \| Bausch Health Companies Inc.	2025-04-01	HUMAN PRESCRIPTION DRUG LABEL	10
Diltiazem Hydrochloride Extended-Release Tablets	Bryant Ranch Prepack	2024-03-21	HUMAN PRESCRIPTION DRUG LABEL	100