BiDil
- Product NDC
- 24338-010
- 11-digit product format
- 243380010
- Labeler code
- 24338
- Product ID
- 24338-010_79524516-67d7-45ef-bf97-878c6dc8d6ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine hydrochloride and Isosorbide dinitrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Azurity Pharmaceuticals, Inc.
- Application
- NDA020727
- Marketing category
- NDA
- Marketing start
- 2012-12-05
- Substance
- HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
- Active strength
- 37.5; 20 mg/1; mg/1
- Pharmacologic classes
- Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC], Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BiDil
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDRALAZINE HYDROCHLORIDE | 37.5 mg/1 |
| ISOSORBIDE DINITRATE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FD171B778Y, IA7306519N |
| Rxcui | 905377, 905379 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 24338-010-09 | BiDil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 13 |
| 24338-010-12 | BiDil | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | | 13 |
| 24338-010-18 | BiDil | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Hydralazine hydrochloride | ACTIVE INGREDIENT | FD171B778Y | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] | 5 | |
| Isosorbide dinitrate | ACTIVE INGREDIENT | IA7306519N | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] | 5 | |
| Hydralazine | ACTIVE MOIETY | 26NAK24LS8 | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] | 5 | |
| Isosorbide dinitrate | ACTIVE MOIETY | IA7306519N | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] | 5 | |
| aluminum oxide | INACTIVE INGREDIENT | LMI26O6933 | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] | 5 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] | 5 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] | 5 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] | 5 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] | 5 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] | 5 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] | 5 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] | 5 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] | 5 | |
| sodium starch glycolate type a potato | INACTIVE INGREDIENT | 5856J3G2A2 | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] | 5 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 24338-010 | BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [AZURITY] | 12 | Current NDC, Legacy NDC, 3 package rows | 20220721_e1e63cd5-d1e4-4af5-bad5-1ad41ea46b00.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 24338-010-09 | 24338001009 | 90 TABLET, FILM COATED in 1 BOTTLE (24338-010-09) | 2020-08-31 | 0000-00-00 | No | No | Current |
| 24338-010-12 | 24338001012 | 12 TABLET, FILM COATED in 1 BOTTLE (24338-010-12) | 2012-12-05 | 2022-01-31 | No | No | Current |
| 24338-010-18 | 24338001018 | 180 TABLET, FILM COATED in 1 BOTTLE (24338-010-18) | 2012-12-05 | 0000-00-00 | No | No | Current |