NITRO-BID

Product NDC: 0281-0326
11-digit product format: 002810326
Labeler code: 0281
Product ID: 0281-0326_0011b0f7-715e-4daf-9e6b-a787a83e18f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitroglycerin
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Savage Laboratories a division of Fougera Pharmaceuticals, LLC
Application: ANDA087355
Marketing category: ANDA
Marketing start: 2009-08-15
Substance: NITROGLYCERIN
Active strength: 20 mg/g
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A087355-001	NITROGLYCERIN	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL	AB	RLD, RS	1988-07-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087355-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL	AB	RLD, RS	1988-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL	AB	RLD, RS	1988-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL	AB	RLD, RS	1988-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL	AB	RLD, RS	1988-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RLD, RS	1988-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087355-001	NITROGLYCERIN	2%	OINTMENT / TRANSDERMAL		RS	1988-07-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A087355-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087355-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087355-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087355-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A087355-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: NITRO-BID
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROGLYCERIN	20 mg/g

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
207273	Internal RxNorm lookup
242946	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
e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	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
0281-0326-08	NITRO-BID	48 in 1 BOX	OINTMENT	48	15
0281-0326-08	NITRO-BID	1 g in 1 PACKET	OINTMENT	1	15
0281-0326-30	NITRO-BID	30 g in 1 TUBE	OINTMENT	30	15
0281-0326-60	NITRO-BID	60 g in 1 TUBE	OINTMENT	60	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0281-0326-08	GM - Gram	0281-0326	af77d083-dc82-4c87-ac9a-49eda2aa5906	1	2012-07-24
0281-0326-30	GM - Gram	0281-0326	bd40409e-e9ee-44a0-bbfd-40079697f24b	1	2012-07-24
0281-0326-60	GM - Gram	0281-0326	9b3daa75-4d2e-40fe-a922-c84571365496	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
nitroglycerin	ACTIVE INGREDIENT	G59M7S0WS3	NITRO-BID (NITROGLYCERIN) OINTMENT [SAVAGE LABORATORIES A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
nitroglycerin	ACTIVE MOIETY	G59M7S0WS3	NITRO-BID (NITROGLYCERIN) OINTMENT [SAVAGE LABORATORIES A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
lactose	INACTIVE INGREDIENT	J2B2A4N98G	NITRO-BID (NITROGLYCERIN) OINTMENT [SAVAGE LABORATORIES A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	NITRO-BID (NITROGLYCERIN) OINTMENT [SAVAGE LABORATORIES A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
water	INACTIVE INGREDIENT	059QF0KO0R	NITRO-BID (NITROGLYCERIN) OINTMENT [SAVAGE LABORATORIES A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0281-0326	NITRO-BID (NITROGLYCERIN) OINTMENT [SAVAGE LABORATORIES A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	13	Current NDC, Legacy NDC, 4 package rows	20240907_e464e9bb-48e8-4b9f-9fff-e220cfbac0c5.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-BID	NITROGLYCERIN	Savage Laboratories a division of Fougera Pharmaceuticals, LLC	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087355 application number: ANDA087355 ndc (product): 0281-0326
NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	7da79fdf-0969-1ddd-e053-2991aa0a3ec4	2022-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087355 application number: ANDA087355

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
207273	NITRO-BID 2 % Topical Ointment	PSN	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	15
242946	nitroglycerin 2 % Topical Ointment	PSN	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	15
207273	nitroglycerin 0.02 MG/MG Topical Ointment [Nitro-Bid]	SBD	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	15
242946	nitroglycerin 0.02 MG/MG Topical Ointment	SCD	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	15
207273	Nitro-Bid 0.02 MG/MG Topical Ointment	SY	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	15
207273	Nitro-Bid 2 % Topical Ointment	SY	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	15
207273	Nitro-Bid 20 MG/GM Topical Ointment	SY	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	15
242946	nitroglycerin 2 % Topical Ointment	SY	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	15
242946	NTG 0.02 MG/MG Topical Ointment	SY	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	15
207273	NTG 0.02 MG/MG Topical Ointment [Nitro-Bid]	SY	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	15
242946	TNG 0.02 MG/MG Topical Ointment	SY	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	15
207273	TNG 0.02 MG/MG Topical Ointment [Nitro-Bid]	SY	e464e9bb-48e8-4b9f-9fff-e220cfbac0c5	15
242946	nitroglycerin 2 % Topical Ointment	PSN	7da79fdf-0969-1ddd-e053-2991aa0a3ec4	4
242946	nitroglycerin 0.02 MG/MG Topical Ointment	SCD	7da79fdf-0969-1ddd-e053-2991aa0a3ec4	4
242946	nitroglycerin 2 % Topical Ointment	SY	7da79fdf-0969-1ddd-e053-2991aa0a3ec4	4
242946	NTG 0.02 MG/MG Topical Ointment	SY	7da79fdf-0969-1ddd-e053-2991aa0a3ec4	4
242946	TNG 0.02 MG/MG Topical Ointment	SY	7da79fdf-0969-1ddd-e053-2991aa0a3ec4	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0281-0326-08	00281032608	48 PACKET in 1 BOX (0281-0326-08) / 1 g in 1 PACKET	48 packet	2009-08-17	0000-00-00	No	No	Current
0281-0326-30	00281032630	30 g in 1 TUBE (0281-0326-30)	30 g	2009-08-17	0000-00-00	No	No	Current
0281-0326-60	00281032660	60 g in 1 TUBE (0281-0326-60)	60 g	2009-08-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NITRO-BID ® (Nitroglycerin Ointment USP, 2%)	Savage Laboratories a division of Fougera Pharmaceuticals, LLC	2026-01-28	HUMAN PRESCRIPTION DRUG LABEL	15
NITRO-BID(R) (NITROGLYCERIN OINTMENT USP, 2%) TUBE	HF Acquisition Co LLC, DBA HealthFirst	2022-12-09	HUMAN PRESCRIPTION DRUG LABEL	4