nitroglycerin

Product NDC: 67296-2313
11-digit product format: 672962313
Labeler code: 67296
Product ID: 67296-2313_594b93af-c27b-0784-e063-6394a90a1280
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nitroglycerin
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Redpharm Drug
Application: ANDA217970
Marketing category: ANDA
Marketing start: 2024-09-01
Substance: NITROGLYCERIN
Active strength: .4 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A217970-001	NITROGLYCERIN	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2023-12-05
A217970-002	NITROGLYCERIN	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2023-12-05
A217970-003	NITROGLYCERIN	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2023-12-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217970-001	AB
A217970-002	AB
A217970-003	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 2 · 60 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	A217970-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2023-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217970-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2023-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217970-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2023-12-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217970-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2023-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217970-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2023-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217970-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2023-12-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217970-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2023-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217970-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2023-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217970-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2023-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217970-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2023-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217970-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2023-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217970-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2023-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217970-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2023-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217970-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2023-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217970-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2023-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217970-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2023-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217970-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2023-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217970-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2023-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217970-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2023-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217970-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2023-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217970-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2023-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217970-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2023-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217970-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2023-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217970-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2023-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217970-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2023-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217970-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2023-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217970-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2023-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217970-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2023-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217970-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2023-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217970-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2023-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217970-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2023-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217970-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2023-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217970-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2023-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217970-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2023-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217970-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2023-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217970-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2023-12-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217970-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2023-12-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217970-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2023-12-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217970-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2023-12-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217970-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2023-12-05	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	A217970-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217970-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217970-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217970-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217970-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217970-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217970-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217970-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217970-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217970-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217970-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217970-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217970-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217970-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217970-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217970-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217970-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217970-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217970-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217970-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217970-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217970-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217970-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217970-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217970-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217970-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217970-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217970-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217970-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217970-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217970-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217970-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217970-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217970-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217970-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217970-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217970-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217970-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217970-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217970-001	AB	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: nitroglycerin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROGLYCERIN	.4 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198039	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
594b939f-d399-835e-e063-6294a90a4422	Available on FDA.report

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nitroglycerin	NITROGLYCERIN	Medical Purchasing Solutions, LLC.	5b150cd2-fac8-86ce-e063-6294a90a67b9	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217970 application number: ANDA217970
nitroglycerin	NITROGLYCERIN	REMEDYREPACK INC.	89da40c1-bab1-422e-b326-8ebcbdbc81f3	2026-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217970 application number: ANDA217970
nitroglycerin	NITROGLYCERIN	Redpharm Drug	594b939f-d399-835e-e063-6294a90a4422	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217970 application number: ANDA217970 ndc (product): 67296-2313
nitroglycerin	NITROGLYCERIN	Medical Purchasing Solutions, LLC	3f7ebc5e-82a7-393d-e063-6394a90a173a	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217970 application number: ANDA217970
nitroglycerin	NITROGLYCERIN	NorthStar RxLLC	141b6098-dd8e-4c99-a581-197d46f9e0b1	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217970 application number: ANDA217970
nitroglycerin	NITROGLYCERIN	Lifestar Pharma LLC	38059df3-be1b-4226-9f12-c3c37cb44fea	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217970 application number: ANDA217970

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2313-2	67296231302	1 BOTTLE in 1 CARTON (67296-2313-2) / 25 TABLET in 1 BOTTLE	1 bottle	2024-09-01	No	No	Current