Isosorbide Dinitrate

Product NDC: 49884-009
11-digit product format: 498840009
Labeler code: 49884
Product ID: 49884-009_bb122d4c-8b22-44dd-9c60-772123f18a4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isosorbide dinitrate
Dosage form: TABLET
Route: ORAL
Labeler: Endo USA, Inc.
Application: ANDA087946
Marketing category: ANDA
Marketing start: 1983-02-10
Substance: ISOSORBIDE DINITRATE
Active strength: 30 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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
ISOSORBIDE DINITRATE	30 mg/1

Field, Values table
Field	Values
Unii	IA7306519N
Rxcui	197839, 206842, 314055, 381056

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e9ed2ee5-d109-4795-bffe-c3b047717749	Product name	2	20250107
1ee44c84-1ad7-16b4-788d-a549f91b0f44	Product name	4	20230316
0dcc68a5-df0d-b1a6-ba71-3da99d94ffe9	Product name	1	20140508
b0c258c1-3fb1-4785-4031-5c4417fb7ecd	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49884-009-01	2022-08-19	C162847	48780-1	e4f33bdf-ad7f-d8a0-e053-dadaa90a6e4e	ISOSORBIDE DINITRATE TABLETS, USP Rx only
49884-009-10	2022-08-19	C162847	48780-1	e4f33bdf-ad7f-d8a0-e053-dadaa90a6e4e	ISOSORBIDE DINITRATE TABLETS, USP Rx only
49884-009-01	2022-07-29	C162847	48780-1	e4f33bdf-ad7f-d8a0-e053-dadaa90a6e4e	ISOSORBIDE DINITRATE TABLETS, USP Rx only
49884-009-10	2022-07-29	C162847	48780-1	e4f33bdf-ad7f-d8a0-e053-dadaa90a6e4e	ISOSORBIDE DINITRATE TABLETS, USP Rx only

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49884-009-01	Isosorbide Dinitrate	100 in 1 BOTTLE	TABLET	100		17
49884-009-10	Isosorbide Dinitrate	1000 in 1 BOTTLE	TABLET	1000		17

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-009-01	EA - Each	49884-009	8317b768-c578-4bd9-86e0-cab672672102	1	2012-07-24
49884-009-10	EA - Each	49884-009	86ec9b09-a7dd-47c4-b73a-09442a075a50	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOSORBIDE DINITRATE	ACTIVE INGREDIENT	IA7306519N	ISOSORBIDE DINITRATE TABLET [PAR PHARMACEUTICAL INC.]	6
ISOSORBIDE DINITRATE	ACTIVE MOIETY	IA7306519N	ISOSORBIDE DINITRATE TABLET [PAR PHARMACEUTICAL INC.]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ISOSORBIDE DINITRATE TABLET [PAR PHARMACEUTICAL INC.]	6
ISOSORBIDE DINITRATE	ACTIVE INGREDIENT	IA7306519N	ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT]	2
ISOSORBIDE DINITRATE	ACTIVE INGREDIENT	IA7306519N	ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT]	2
ISOSORBIDE DINITRATE	ACTIVE MOIETY	IA7306519N	ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT]	2
ISOSORBIDE DINITRATE	ACTIVE MOIETY	IA7306519N	ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ISOSORBIDE DINITRATE TABLET [CARILION MATERIALS MANAGEMENT]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-009	ISOSORBIDE DINITRATE TABLET [ENDO USA, INC.]	17	Current NDC, Legacy NDC, 2 package rows	20240926_6df6a2fa-c56c-4eb6-a485-c16585420eb0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IA7306519N	ISOSORBIDE DINITRATE	87-33-2	ISOSORBIDE DINITRATE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
381056	isosorbide dinitrate 10 MG Oral Tablet	PSN	6df6a2fa-c56c-4eb6-a485-c16585420eb0	17
206842	isosorbide dinitrate 20 MG Oral Tablet	PSN	6df6a2fa-c56c-4eb6-a485-c16585420eb0	17
197839	isosorbide dinitrate 30 MG Oral Tablet	PSN	6df6a2fa-c56c-4eb6-a485-c16585420eb0	17
314055	isosorbide dinitrate 5 MG Oral Tablet	PSN	6df6a2fa-c56c-4eb6-a485-c16585420eb0	17
381056	isosorbide dinitrate 10 MG Oral Tablet	SCD	6df6a2fa-c56c-4eb6-a485-c16585420eb0	17
206842	isosorbide dinitrate 20 MG Oral Tablet	SCD	6df6a2fa-c56c-4eb6-a485-c16585420eb0	17
197839	isosorbide dinitrate 30 MG Oral Tablet	SCD	6df6a2fa-c56c-4eb6-a485-c16585420eb0	17
314055	isosorbide dinitrate 5 MG Oral Tablet	SCD	6df6a2fa-c56c-4eb6-a485-c16585420eb0	17
381056	ISDN 10 MG Oral Tablet	SY	6df6a2fa-c56c-4eb6-a485-c16585420eb0	17
206842	ISDN 20 MG Oral Tablet	SY	6df6a2fa-c56c-4eb6-a485-c16585420eb0	17
197839	ISDN 30 MG Oral Tablet	SY	6df6a2fa-c56c-4eb6-a485-c16585420eb0	17
314055	ISDN 5 MG Oral Tablet	SY	6df6a2fa-c56c-4eb6-a485-c16585420eb0	17
197839	isosorbide dinitrate 30 MG Oral Tablet	PSN	ad51e5ef-31e6-470b-9332-dab8d1533483	4
197839	isosorbide dinitrate 30 MG Oral Tablet	PSN	d25fc9aa-742f-4a90-8fd9-2a3741864cd2	4
197839	isosorbide dinitrate 30 MG Oral Tablet	SCD	ad51e5ef-31e6-470b-9332-dab8d1533483	4
197839	isosorbide dinitrate 30 MG Oral Tablet	SCD	d25fc9aa-742f-4a90-8fd9-2a3741864cd2	4
197839	ISDN 30 MG Oral Tablet	SY	ad51e5ef-31e6-470b-9332-dab8d1533483	4
197839	ISDN 30 MG Oral Tablet	SY	d25fc9aa-742f-4a90-8fd9-2a3741864cd2	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-009-01	49884000901	100 TABLET in 1 BOTTLE (49884-009-01)	100 tablet	1983-02-10	0000-00-00	No	No	Current
49884-009-10	49884000910	1000 TABLET in 1 BOTTLE (49884-009-10)	1000 tablet	1983-02-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ISOSORBIDE DINITRATE TABLETS, USP Rx only	Endo USA, Inc.	2024-09-24	HUMAN PRESCRIPTION DRUG LABEL	17
Isosorbide Dinitrate - Carilion Materials Management	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4
Isosorbide Dinitrate - Carilion Materials Management	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4