Prescription drug · ANDA
nitrofurantoin macrocrystals NDC 0904-7026
Nitrofurantoin 50 mg/1 · Capsule · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7026-61 | 0090470266100904702661 | 100 BLISTER PACK in 1 CARTON (0904-7026-61) / 1 CAPSULE in 1 BLISTER PACKMarketed from Feb 15, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- nitrofurantoin macrocrystals
- Generic name (nonproprietary)
- nitrofurantoin macrocrystals
- Active ingredients
- Nitrofurantoin — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205005
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)
- Identifiers
- Product ID 0904-7026_8d3d6cd5-653a-499e-bc06-78ced2a4d334SPL ID 8d3d6cd5-653a-499e-bc06-78ced2a4d334SPL set ID 3ee5e79f-1dca-4e1b-95a9-7859bfe344d1RxCUI 311995UNII 927AH8112L
- Pharmacologic class
- Nitrofuran Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400904702661followed by a unit qualifier and the quantityPackage 00904-7026-61. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE: Nitrofurantoin macrocrystals capsules are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli , enterococci, Staphylococcus aureus , and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin macrocrystals capsules and other antibacterial drugs, nitrofurantoin macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptibl…
Excerpt only. Read the full label for complete information.
About NDC 0904-7026
- What is NDC 0904-7026?
- 0904-7026 is the product NDC for nitrofurantoin macrocrystals, Nitrofurantoin 50 mg/1 capsule, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- nitrofurantoin macrocrystals.
- What is the active ingredient?
- Nitrofurantoin.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for nitrofurantoin macrocrystals?
- 38 other product NDCs are listed under this name. See all nitrofurantoin macrocrystals NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other nitrofurantoin macrocrystals products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| nitrofurantoin (macrocrystals) | Nitrofurantoin 25 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-942 | 59651-0942-01 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | American Health Packaging | 60687-839 | 60687-0839-01 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | American Health Packaging | 60687-850 | 60687-0850-01 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Direct_Rx | 61919-842 | 61919-0842-1461919-0842-20 |
| nitrofurantoin macrocrystals | Nitrofurantoin 25 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-182 | 72603-0182-01 |
| nitrofurantoin macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-183 | 72603-0183-01 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-184 | 72603-0184-01 |
| nitrofurantoin macrocrystals | Nitrofurantoin 25 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-603 | 68001-0603-00 |
| nitrofurantoin macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-604 | 68001-0604-00 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-605 | 68001-0605-00 |
Other NDCs under ANDA 205005
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| nitrofurantoinnitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1069 |
| nitrofurantoin macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | Zydus Pharmaceuticals (USA) Inc. | 68382-559 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Zydus Pharmaceuticals (USA) Inc. | 68382-560 |
| nitrofurantoin macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1170 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1171 |