nitrofurantoin macrocrystals
- Product NDC
- 47781-308
- 11-digit product format
- 477810308
- Labeler code
- 47781
- Product ID
- 47781-308_97785cf3-ab56-4697-3ab6-7451919d889a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitrofurantoin macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Alvogen Inc.
- Application
- NDA016620
- Marketing category
- NDA
- Marketing start
- 2010-09-27
- Substance
- NITROFURANTOIN
- Active strength
- 100 mg/1
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- nitrofurantoin macrocrystals
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROFURANTOIN | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L |
| Rxcui | 311994, 311995, 1648759 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47781-308-01 | nitrofurantoin macrocrystals | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47781-308 | NITROFURANTOIN MACROCRYSTALS CAPSULE [ALVOGEN INC. ] | 18 | Current NDC, Legacy NDC, 1 package rows | 20241018_62c1bb9c-79a2-41e3-9dfa-352f92253881.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | 62c1bb9c-79a2-41e3-9dfa-352f92253881 | 19 |
| 311994 | nitrofurantoin macrocrystals 25 MG Oral Capsule | PSN | 62c1bb9c-79a2-41e3-9dfa-352f92253881 | 19 |
| 311995 | nitrofurantoin macrocrystals 50 MG Oral Capsule | PSN | 62c1bb9c-79a2-41e3-9dfa-352f92253881 | 19 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | 62c1bb9c-79a2-41e3-9dfa-352f92253881 | 19 |
| 311994 | nitrofurantoin, macrocrystals 25 MG Oral Capsule | SCD | 62c1bb9c-79a2-41e3-9dfa-352f92253881 | 19 |
| 311995 | nitrofurantoin, macrocrystals 50 MG Oral Capsule | SCD | 62c1bb9c-79a2-41e3-9dfa-352f92253881 | 19 |
| 311994 | nitrofurantoin macrocrystals 25 MG Oral Capsule | SY | 62c1bb9c-79a2-41e3-9dfa-352f92253881 | 19 |
| 311995 | nitrofurantoin macrocrystals 50 MG Oral Capsule | SY | 62c1bb9c-79a2-41e3-9dfa-352f92253881 | 19 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | 3b53f9bf-866a-4cb1-9180-7b13896e26ba | 6 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | 3b53f9bf-866a-4cb1-9180-7b13896e26ba | 6 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | 137b8d13-2e41-4990-8714-4c66c3982be8 | 5 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | f78102eb-cbed-801a-e053-6294a90ab880 | 5 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | f78102eb-cbed-801a-e053-6294a90ab880 | 5 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | 137b8d13-2e41-4990-8714-4c66c3982be8 | 5 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | 66474d1d-afc8-f611-e053-2a91aa0acbf5 | 3 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | 66474d1d-afc8-f611-e053-2a91aa0acbf5 | 3 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | b7581146-886b-4fd3-aa64-2e6dc6832aee | 2 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | b7581146-886b-4fd3-aa64-2e6dc6832aee | 2 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | 3281e6f9-c147-4473-8617-e0ad3352a848 | 1 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | d4b372d8-88f8-42c2-87ea-61302258c917 | 1 |
| 1648759 | nitrofurantoin macrocrystals 100 MG Oral Capsule | PSN | 27fa784f-0859-0b97-e054-00144ff8d46c | 1 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | 3281e6f9-c147-4473-8617-e0ad3352a848 | 1 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | 27fa784f-0859-0b97-e054-00144ff8d46c | 1 |
| 1648759 | nitrofurantoin, macrocrystals 100 MG Oral Capsule | SCD | d4b372d8-88f8-42c2-87ea-61302258c917 | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47781-308-01 | 47781030801 | 100 CAPSULE in 1 BOTTLE, PLASTIC (47781-308-01) | 100 capsule | 2010-09-27 | 0000-00-00 | No | No | Current |