Nitrofurantoin Monohydrate/ Macrocrystalline
- Product NDC
- 53002-7040
- 11-digit product format
- 530027040
- Labeler code
- 53002
- Product ID
- 53002-7040_aa0226fd-ce75-435f-9715-17e70bf48f76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin Monohydrate/Macrocrystalline
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- NDA020064
- Marketing category
- NDA
- Marketing start
- 2011-05-25
- Marketing end
- 0000-00-00
- Substance
- NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
- Active strength
- 25 mg/1; mg/1
- Pharmacologic classes
- Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 53002-7040-1 | Nitrofurantoin Monohydrate/ Macrocrystalline | 6 in 1 BOTTLE | CAPSULE | 6 | | 5 |
| 53002-7040-2 | Nitrofurantoin Monohydrate/ Macrocrystalline | 10 in 1 BOTTLE | CAPSULE | 10 | | 5 |
| 53002-7040-3 | Nitrofurantoin Monohydrate/ Macrocrystalline | 14 in 1 BOTTLE | CAPSULE | 14 | | 5 |
| 53002-7040-4 | Nitrofurantoin Monohydrate/ Macrocrystalline | 20 in 1 BOTTLE | CAPSULE | 20 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-7040 | NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 4 package rows | 20230609_d97f0977-89e0-4918-aceb-1bbc1e322748.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-7040-1 | 53002704001 | 6 CAPSULE in 1 BOTTLE (53002-7040-1) | 6 capsule | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-7040-2 | 53002704002 | 10 CAPSULE in 1 BOTTLE (53002-7040-2) | 10 capsule | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-7040-3 | 53002704003 | 14 CAPSULE in 1 BOTTLE (53002-7040-3) | 14 capsule | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-7040-4 | 53002704004 | 20 CAPSULE in 1 BOTTLE (53002-7040-4) | 20 capsule | 2017-10-01 | 0000-00-00 | No | No | Current |