NDC 68071-4367-01 - Nitrofurantoin (monohydrate/macrocrystals)
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68071-4367
- Requested NDC
- 68071-4367-01
- Package NDCs from labels
- 68071-4367-4, 68071-4367-2, 68071-4367-1, 68071-4367-01
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2024-12-30
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) | NuCare Pharmaceuticals,Inc. | 2024-12-30 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 68071-4367-2 | 2023-02-22 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) |
| 68071-4367-4 | 2023-02-22 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) |
| 68071-4367-2 | 2023-01-30 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) |
| 68071-4367-4 | 2023-01-30 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) |
| 68071-4367-2 | 2021-02-16 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) |
| 68071-4367-4 | 2021-02-16 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) |
| 68071-4367-2 | 2021-01-29 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) |
| 68071-4367-4 | 2021-01-29 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-4367-1 | Nitrofurantoin (monohydrate/macrocrystals) | 10 in 1 BOTTLE | CAPSULE | 10 | 6 | |
| 68071-4367-2 | Nitrofurantoin (monohydrate/macrocrystals) | 20 in 1 BOTTLE | CAPSULE | 20 | 6 | |
| 68071-4367-4 | Nitrofurantoin (monohydrate/macrocrystals) | 14 in 1 BOTTLE | CAPSULE | 14 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-4367 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NUCARE PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20250101_68a651f9-1aef-792e-e053-2991aa0a3cbb.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f031e256-fca5-3939-e053-2995a90a4fe6 | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| SILICEA | SILICON DIOXIDE | Hyland's Inc. | 86da31ff-b39a-4ac2-92e5-810f6d8888e6 | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f0328097-e5d2-3532-e053-2a95a90a93f0 | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f032e7bb-a6fd-2951-e053-2a95a90a8c3a | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Silicea | SILICON DIOXIDE | Hyland's Inc. | d3c426ab-1a61-3494-e053-2a95a90a9677 | 2022-12-14 | Warnings | ETJ7Z6XBU4 |
| Silicea | SILICEA | Hahnemann Laboratories, INC. | efcdc393-5dab-38d1-e053-2995a90acb2e | 2022-12-14 | ETJ7Z6XBU4 | |
| Defend Cold and Mucus | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | bb851be1-0528-4199-91e7-e09f994b2862 | 2022-12-12 | Warnings | ETJ7Z6XBU4 |
| Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic Combination | CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA | OHM PHARMA INC. | 044a7174-f7a3-490f-9cad-01f2665d7575 | 2022-12-02 | Warnings | ETJ7Z6XBU4 |
| 4 Kids Cold and Mucus Nighttime | EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFUR | Hyland's Inc. | 6f7b2585-2f0e-5938-e053-2a91aa0aa9d1 | 2022-11-21 | Warnings | ETJ7Z6XBU4 |
| 4 Kids Complete Cold and Mucus | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | ef39fe3d-a42d-4baa-9199-91f664feb432 | 2022-11-21 | Warnings | ETJ7Z6XBU4 |
| Nitrofurantoin | NITROFURANTOIN | Proficient Rx LP | 34d3c103-27b8-454b-9f38-c33157c3b6fc | 2022-11-01 | Warnings, Adverse reactions | 1648755 E1QI2CQQ1I 927AH8112L |
| Nitrofurantoin Mono | NITROFURANTOIN MONOHYDRATE | PharmPak, Inc. | d9840719-271f-42a9-a5c9-3e039ec8fbac | 2022-10-09 | Warnings, Adverse reactions | 1648755 E1QI2CQQ1I 927AH8112L |
| Nitrofurantoin Monohydrate/ Macrocrystalline | NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE | Proficient Rx LP | 22061f76-2c05-4501-b8dd-a5c372abe7c2 | 2022-10-01 | Warnings, Adverse reactions | 1648755 E1QI2CQQ1I 927AH8112L |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Asclemed USA, Inc. | 1ab658f0-021a-46a1-bff3-d3334c23442d | 2022-09-21 | Warnings, Adverse reactions | ANDA077066 1648755 E1QI2CQQ1I 927AH8112L |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Proficient Rx LP | d802d734-dc8f-4f3c-bce6-aaccc4614c89 | 2022-09-01 | Warnings, Adverse reactions | ANDA077066 1648755 E1QI2CQQ1I 927AH8112L |
| Hendel Periodontal and Tooth Pain Relief | SODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDE | MediNatura Inc | f34e9f77-69fd-4c7f-9eea-2d721a4d27fb | 2022-08-22 | Warnings | ETJ7Z6XBU4 |
| Nitrofurantoin | NITROFURANTOIN | Lupin Pharmaceuticals,Inc. | 93c37857-38f1-4e2e-acb8-4846840e3e85 | 2022-06-02 | Warnings, Adverse reactions | 927AH8112L |
| Addiclenz | BETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | Deseret Biologicals, Inc. | e39235ea-2a2f-44a7-92d6-fb1d428ebabd | 2022-05-12 | Warnings | 15FIX9V2JP |
| Nitrofurantion | NITROFURANTION | Proficient Rx LP | 870f64ca-0256-4e3f-8c34-dc603ccc41c0 | 2022-05-02 | Warnings, Adverse reactions | 927AH8112L |
| ALPHA SH | SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS | Schwabe Mexico, S.A. de C.V. | 3e2e5f52-db54-4635-83a8-a67a683c093c | 2022-03-22 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.