Nitroglycerin

Product NDC: 68462-638
11-digit product format: 684620638
Labeler code: 68462
Product ID: 68462-638_76e69387-efc6-4816-972c-765cb260b34a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitroglycerin
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA206391
Marketing category: ANDA
Marketing start: 2017-08-19
Substance: NITROGLYCERIN
Active strength: .3 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206391-001	NITROGLYCERIN	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19
A206391-002	NITROGLYCERIN	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19
A206391-003	NITROGLYCERIN	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206391-001	AB
A206391-002	AB
A206391-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206391-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2017-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206391-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2017-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206391-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2017-09-19	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A206391-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206391-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206391-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206391-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206391-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206391-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206391-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206391-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206391-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206391-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206391-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206391-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206391-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206391-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206391-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206391-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206391-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206391-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206391-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206391-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206391-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206391-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206391-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206391-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206391-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206391-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206391-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206391-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206391-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206391-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206391-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206391-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206391-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206391-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206391-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206391-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206391-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206391-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206391-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206391-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROGLYCERIN	.3 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198038	Internal RxNorm lookup
198039	Internal RxNorm lookup
198040	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
fa789d65-9407-4965-bd06-4457444b42be	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
68462-638-01	Nitroglycerin	100 in 1 BOTTLE	TABLET	100		10
68462-638-01	Nitroglycerin	1 in 1 CARTON	TABLET	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-638-01	EA - Each	68462-638	91ed9a77-7b50-4665-acd9-e31256e672e9	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-638	NITROGLYCERIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]	9	Current NDC, Legacy NDC, 2 package rows	20240104_fa789d65-9407-4965-bd06-4457444b42be.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitroglycerin	NITROGLYCERIN	A-S Medication Solutions	532e30c4-cbda-4450-b0a0-e08601c202fb	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206391 application number: ANDA206391
Nitroglycerin	NITROGLYCERIN	Glenmark Pharmaceuticals Inc., USA	fa789d65-9407-4965-bd06-4457444b42be	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206391 application number: ANDA206391 ndc (product): 68462-638
Nitroglycerin	NITROGLYCERIN	ProPharma Distribution	3d71f76d-bb22-7251-e063-6394a90aa9d8	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206391 application number: ANDA206391
Nitroglycerin	NITROGLYCERIN	NuCare Pharmaceuticals, Inc.	2bad7976-4eb0-d064-e063-6394a90a75de	2025-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206391 application number: ANDA206391
Nitroglycerin	NITROGLYCERIN	Proficient Rx LP	41fe1f25-bfd0-4eaf-973d-bdb6b5d70f93	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206391 application number: ANDA206391
Nitroglycerin	NITROGLYCERIN	Medical Purchasing Solutions, LLC	8959095a-8cd8-f7d4-e053-2995a90a6e8f	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206391 application number: ANDA206391

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
198038	nitroglycerin 0.3 MG Sublingual Tablet	PSN	fa789d65-9407-4965-bd06-4457444b42be	10
198039	nitroglycerin 0.4 MG Sublingual Tablet	PSN	fa789d65-9407-4965-bd06-4457444b42be	10
198040	nitroglycerin 0.6 MG Sublingual Tablet	PSN	fa789d65-9407-4965-bd06-4457444b42be	10
198038	nitroglycerin 0.3 MG Sublingual Tablet	SCD	fa789d65-9407-4965-bd06-4457444b42be	10
198039	nitroglycerin 0.4 MG Sublingual Tablet	SCD	fa789d65-9407-4965-bd06-4457444b42be	10
198040	nitroglycerin 0.6 MG Sublingual Tablet	SCD	fa789d65-9407-4965-bd06-4457444b42be	10
198038	nitroglycerin 300 MCG Sublingual Tablet	SY	fa789d65-9407-4965-bd06-4457444b42be	10
198039	nitroglycerin 400 MCG Sublingual Tablet	SY	fa789d65-9407-4965-bd06-4457444b42be	10
198040	nitroglycerin 600 MCG Sublingual Tablet	SY	fa789d65-9407-4965-bd06-4457444b42be	10
198038	NTG 0.3 MG Sublingual Tablet	SY	fa789d65-9407-4965-bd06-4457444b42be	10
198039	NTG 0.4 MG Sublingual Tablet	SY	fa789d65-9407-4965-bd06-4457444b42be	10
198040	NTG 0.6 MG Sublingual Tablet	SY	fa789d65-9407-4965-bd06-4457444b42be	10
198038	TNG 0.3 MG Sublingual Tablet	SY	fa789d65-9407-4965-bd06-4457444b42be	10
198039	TNG 0.4 MG Sublingual Tablet	SY	fa789d65-9407-4965-bd06-4457444b42be	10
198040	TNG 0.6 MG Sublingual Tablet	SY	fa789d65-9407-4965-bd06-4457444b42be	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-638-01	68462063801	1 BOTTLE in 1 CARTON (68462-638-01) / 100 TABLET in 1 BOTTLE	1 bottle	2017-08-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitroglycerin	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	10