Nitroglycerin Transdermal Infusion System

Product NDC: 43598-895
11-digit product format: 435980895
Labeler code: 43598
Product ID: 43598-895_10b34299-d60a-f785-70d6-2e5cc344638c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitroglycerin
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Dr. Reddy's Laboratories, Inc.
Application: NDA020145
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-03-01
Substance: NITROGLYCERIN
Active strength: 40 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
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	RLD / RS	Approval date
N020145-001	NITRO-DUR	NITROGLYCERIN	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1995-04-04
N020145-002	NITRO-DUR	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1995-04-04
N020145-003	NITRO-DUR	NITROGLYCERIN	0.3MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1995-04-04
N020145-004	NITRO-DUR	NITROGLYCERIN	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04
N020145-005	NITRO-DUR	NITROGLYCERIN	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1995-04-04
N020145-006	NITRO-DUR	NITROGLYCERIN	0.8MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1995-04-04

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020145-001	NITRO-DUR	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1995-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020145-002	NITRO-DUR	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1995-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020145-003	NITRO-DUR	0.3MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1995-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020145-004	NITRO-DUR	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020145-005	NITRO-DUR	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1995-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020145-006	NITRO-DUR	0.8MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1995-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020145-001	NITRO-DUR	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020145-002	NITRO-DUR	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020145-003	NITRO-DUR	0.3MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020145-004	NITRO-DUR	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020145-005	NITRO-DUR	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020145-006	NITRO-DUR	0.8MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020145-001	NITRO-DUR	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020145-002	NITRO-DUR	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020145-003	NITRO-DUR	0.3MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020145-004	NITRO-DUR	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020145-005	NITRO-DUR	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020145-006	NITRO-DUR	0.8MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020145-001	NITRO-DUR	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020145-002	NITRO-DUR	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020145-003	NITRO-DUR	0.3MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020145-004	NITRO-DUR	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020145-005	NITRO-DUR	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020145-006	NITRO-DUR	0.8MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020145-001	NITRO-DUR	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020145-002	NITRO-DUR	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020145-003	NITRO-DUR	0.3MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020145-004	NITRO-DUR	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020145-005	NITRO-DUR	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020145-006	NITRO-DUR	0.8MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020145-001	NITRO-DUR	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020145-002	NITRO-DUR	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020145-003	NITRO-DUR	0.3MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020145-004	NITRO-DUR	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020145-005	NITRO-DUR	0.6MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020145-006	NITRO-DUR	0.8MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020145-001	NITRO-DUR	0.1MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020145-002	NITRO-DUR	0.2MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020145-003	NITRO-DUR	0.3MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020145-004	NITRO-DUR	0.4MG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1995-04-04	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020145-001	BX	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020145-002	BX	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020145-004	BX	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020145-005	BX	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020145-001	BX	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020145-002	BX	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020145-004	BX	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020145-005	BX	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020145-001	BX	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020145-002	BX	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020145-004	BX	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020145-005	BX	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020145-001	BX	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020145-002	BX	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020145-004	BX	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020145-005	BX	1	`c0c555d07b60…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nitroglycerin Transdermal Infusion System
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROGLYCERIN	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G59M7S0WS3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
486146	Internal RxNorm lookup
486148	Internal RxNorm lookup
486152	Internal RxNorm lookup
861657	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
4f85d2e0-2e37-fcd1-276d-5a6466554289	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7480e90b-004b-ebe4-2243-4f2fefdd9e78	Product name	2	20260128
3f158398-73f2-4b90-47d1-5c60e8719a98	Product name	9	20250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0	Product name	2	20250117
00358076-c817-430b-b924-11d717dc307c	Product name	1	20160718
669af5aa-14f3-3df7-f100-5f580ffd43c1	Product name	1	20140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fb	Product name	1	20140508
8bb82a1c-d0d0-fc27-011f-172e545f0382	Product name	1	20140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43598-895-30	Nitroglycerin Transdermal Infusion System	1 in 1 POUCH	PATCH	1		2
43598-895-30	Nitroglycerin Transdermal Infusion System	30 in 1 BOX, UNIT-DOSE	PATCH	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-895-30	EA - Each	43598-895	5bb66b15-78e5-4cd9-8c09-332403a4b3cf	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-895	NITROGLYCERIN TRANSDERMAL INFUSION SYSTEM (NITROGLYCERIN) PATCH [DR. REDDY'S LABORATORIES, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20200414_4f85d2e0-2e37-fcd1-276d-5a6466554289.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
NITRO-DUR	NITROGLYCERIN	Ingenus Pharmaceuticals, LLC	5e15296c-5acd-4bcc-80a8-b49cb1ef3eb0	2023-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020145 application number: NDA020145
Nitroglycerin Transdermal Infusion System	NITROGLYCERIN	Dr. Reddy's Laboratories, Inc.	4f85d2e0-2e37-fcd1-276d-5a6466554289	2020-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020145 application number: NDA020145 ndc (product): 43598-895

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G59M7S0WS3	NITROGLYCERIN	55-63-0	NITROGLYCERIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861657	nitroglycerin 0.1 MG/HR 24HR Transdermal System	PSN	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486148	nitroglycerin 0.2 MG/HR 24HR Transdermal System	PSN	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486152	nitroglycerin 0.4 MG/HR 24HR Transdermal System	PSN	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486146	nitroglycerin 0.6 MG/HR 24HR Transdermal System	PSN	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
861657	24 HR nitroglycerin 0.1 MG/HR Transdermal System	SCD	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486148	24 HR nitroglycerin 0.2 MG/HR Transdermal System	SCD	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486152	24 HR nitroglycerin 0.4 MG/HR Transdermal System	SCD	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486146	24 HR nitroglycerin 0.6 MG/HR Transdermal System	SCD	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
861657	24 HR NTG 0.1 MG/HR Transdermal System	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486148	24 HR NTG 0.2 MG/HR Transdermal System	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486152	24 HR NTG 0.4 MG/HR Transdermal System	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486146	24 HR NTG 0.6 MG/HR Transdermal System	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
861657	24 HR TNG 0.1 MG/HR Transdermal System	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486148	24 HR TNG 0.2 MG/HR Transdermal System	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486152	24 HR TNG 0.4 MG/HR Transdermal System	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486146	24 HR TNG 0.6 MG/HR Transdermal System	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
861657	nitroglycerin 0.1 MG/HR 24 HR Transdermal Patch	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
861657	nitroglycerin 0.1 MG/HR 24HR Transdermal System	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486148	nitroglycerin 0.2 MG/HR 24HR Transdermal System	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486152	nitroglycerin 0.4 MG/HR 24HR Transdermal System	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486146	nitroglycerin 0.6 MG/HR 24HR Transdermal System	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486152	nitroglycerin 10 MG/Day 24 HR Transdermal Patch	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486146	nitroglycerin 14 MG/Day 24 HR Transdermal Patch	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2
486148	nitroglycerin 5 MG/Day 24 HR Transdermal Patch	SY	4f85d2e0-2e37-fcd1-276d-5a6466554289	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-895-30	43598089530	30 POUCH in 1 BOX, UNIT-DOSE (43598-895-30) / 1 PATCH in 1 POUCH	30 pouch	2020-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitroglycerin Transdermal Infusion System	Dr. Reddy's Laboratories, Inc. \| USpharma Ltd	2020-02-26	HUMAN PRESCRIPTION DRUG LABEL	2