nitroglycerin

Product NDC: 47781-456
Requested package NDC: 47781-456-01
11-digit product format: 477810456
Labeler code: 47781
Product ID: 47781-456_161c015a-aec1-c56a-2b58-98572cab765b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nitroglycerin
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Alvogen Inc.
Application: ANDA211604
Marketing category: ANDA
Marketing start: 2019-04-30
Marketing end: 2024-06-01
Substance: NITROGLYCERIN
Active strength: 0 mg/1
Pharmacologic classes: Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	47781-456	47781-456-01	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
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 · 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211604-002	NITROGLYCERIN	0.4MG	TABLET / SUBLINGUAL	AB	2019-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211604-003	NITROGLYCERIN	0.6MG	TABLET / SUBLINGUAL	AB	2019-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211604-001	NITROGLYCERIN	0.3MG	TABLET / SUBLINGUAL	AB	2019-04-30	`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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211604-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211604-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211604-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211604-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211604-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211604-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47781-456-01	EA - Each	47781-456	9c2d9a93-9184-4cb6-951e-6d6e9705b53b	1	2019-12-10

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47781-456-01	47781045601	1 BOTTLE in 1 CARTON (47781-456-01) > 100 TABLET in 1 BOTTLE	1 bottle	2019-08-12	2024-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
nitroglycerin	Bryant Ranch Prepack	2023-03-15	HUMAN PRESCRIPTION DRUG LABEL	102
nitroglycerin	Alvogen Inc.	2022-09-12	HUMAN PRESCRIPTION DRUG LABEL	4