NITROGLYCERIN

Product NDC: 85766-116
Requested package NDC: 85766-116-60
11-digit product format: 857660116
Labeler code: 85766
Product ID: 85766-116_50321bf1-3be4-6a2b-e063-6394a90aa218
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NITROGLYCERIN
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Sportpharm LLC
Application: ANDA211604
Marketing category: ANDA
Marketing start: 2022-10-03
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
A211604-001	NITROGLYCERIN	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30
A211604-002	NITROGLYCERIN	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30
A211604-003	NITROGLYCERIN	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211604-001	AB
A211604-002	AB
A211604-003	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 · 129 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	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A211604-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211604-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211604-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211604-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211604-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211604-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211604-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211604-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211604-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211604-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211604-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211604-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211604-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211604-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211604-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211604-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211604-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211604-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211604-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211604-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211604-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211604-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211604-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211604-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211604-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211604-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211604-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211604-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211604-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211604-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211604-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211604-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211604-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211604-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211604-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211604-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211604-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211604-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211604-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211604-001	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
84739085-81df-4a43-8456-c9edfbf971e9	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	SPL version
85766-116-00	NITROGLYCERIN	25 in 1 BOTTLE	TABLET	25	2
85766-116-00	NITROGLYCERIN	4 in 1 CARTON	TABLET	4	2
85766-116-01	NITROGLYCERIN	1 in 1 CARTON	TABLET	1	2
85766-116-01	NITROGLYCERIN	100 in 1 BOTTLE	TABLET	100	2
85766-116-10	NITROGLYCERIN	10 in 1 BOTTLE	TABLET	10	2
85766-116-20	NITROGLYCERIN	20 in 1 BOTTLE	TABLET	20	2
85766-116-25	NITROGLYCERIN	25 in 1 BOTTLE	TABLET	25	2
85766-116-30	NITROGLYCERIN	30 in 1 BOTTLE	TABLET	30	2
85766-116-60	NITROGLYCERIN	60 in 1 BOTTLE	TABLET	60	2
85766-116-90	NITROGLYCERIN	90 in 1 BOTTLE	TABLET	90	2

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	Sportpharm LLC	84739085-81df-4a43-8456-c9edfbf971e9	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211604 application number: ANDA211604 ndc (package): 85766-116-60 ndc (product): 85766-116 ndc11 (package): 85766011660
NITROGLYCERIN	NITROGLYCERIN	Redpharm Drug	3dd022d8-c224-d19f-e063-6394a90adca4	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211604 application number: ANDA211604
NITROGLYCERIN	NITROGLYCERIN	NuCare Pharmaceuticals,Inc.	f4ea9ad1-a71f-7cea-e053-2a95a90a106d	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211604 application number: ANDA211604
NITROGLYCERIN	NITROGLYCERIN	Proficient Rx LP	160b85ac-d964-463b-9f1e-1429f14ed318	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211604 application number: ANDA211604
NITROGLYCERIN	NITROGLYCERIN	Natco Pharma USA LLC	941ac242-120e-47c1-ac03-50026ff93dd6	2023-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211604 application number: ANDA211604
NITROGLYCERIN	NITROGLYCERIN	Medical Purchasing Solutions, LL	f9b52553-5a26-d374-e053-6294a90a40c7	2023-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211604 application number: ANDA211604

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
198039	nitroglycerin 0.4 MG Sublingual Tablet	PSN	84739085-81df-4a43-8456-c9edfbf971e9	2
198039	nitroglycerin 0.4 MG Sublingual Tablet	SCD	84739085-81df-4a43-8456-c9edfbf971e9	2
198039	nitroglycerin 400 MCG Sublingual Tablet	SY	84739085-81df-4a43-8456-c9edfbf971e9	2
198039	NTG 0.4 MG Sublingual Tablet	SY	84739085-81df-4a43-8456-c9edfbf971e9	2
198039	TNG 0.4 MG Sublingual Tablet	SY	84739085-81df-4a43-8456-c9edfbf971e9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85766-116-60	85766011660	60 TABLET in 1 BOTTLE (85766-116-60)	60 tablet	2025-10-31	No	No	Current