Nitrofurantoin Macrocrystals
- Product NDC
- 10544-601
- 11-digit product format
- 105440601
- Labeler code
- 10544
- Product ID
- 10544-601_2027c67a-6460-4013-bc09-0b2fe84ba35a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin Macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA073652
- Marketing category
- ANDA
- Marketing start
- 2010-04-23
- Marketing end
- 0000-00-00
- Substance
- NITROFURANTOIN
- Active strength
- 100 mg/1
- Pharmacologic classes
- Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-601-20 | Nitrofurantoin Macrocrystals | 20 in 1 BOTTLE | CAPSULE | 20 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NITROFURANTOIN | ACTIVE INGREDIENT | 927AH8112L | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| NITROFURANTOIN | ACTIVE MOIETY | 927AH8112L | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-601 | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 1 package rows | 20110607_013433a1-c27c-4712-a03b-0949b2969fbb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-601-20 | 10544060120 | 20 in 1 BOTTLE | Historical |