Prescription drug · ANDA
Nitrofurantoin (monohydrate/macrocrystals) NDC 70756-404
Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 · Capsule · Oral · Lifestar Pharma LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)70756-404Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70756-0404Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70756-404-11 | 7075604041170756040411 | 100 CAPSULE in 1 BOTTLE (70756-404-11)Marketed from Sep 14, 2023 | |
| 70756-404-51 | 7075604045170756040451 | 500 CAPSULE in 1 BOTTLE (70756-404-51)Marketed from Sep 14, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 (monohydrate/macrocrystals)
- Generic name (nonproprietary)
- nitrofurantoin (monohydrate/macrocrystals)
- Active ingredients
- Nitrofurantoin monohydrate — 75 mg/1Nitrofurantoin — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Lifestar Pharma LLCNDC labeler code 70756
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217357
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)Nitrofurans (Chemical structure)
- Identifiers
- Product ID 70756-404_03bd4661-52d3-4e0c-a70f-bfb3f286df78SPL ID 03bd4661-52d3-4e0c-a70f-bfb3f286df78
- 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
N470756040411followed by a unit qualifier and the quantityPackage 70756-0404-11. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70756-404
- What is NDC 70756-404?
- 70756-404 is the product NDC for Nitrofurantoin (monohydrate/macrocrystals), Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 capsule, listed with the FDA by Lifestar Pharma LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitrofurantoin (monohydrate/macrocrystals).
- What is the active ingredient?
- Nitrofurantoin monohydrate, Nitrofurantoin.
- Who is the labeler?
- Lifestar Pharma LLC, NDC labeler code 70756. 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 (monohydrate/macrocrystals)?
- 32 other product NDCs are listed under this name. See all Nitrofurantoin (monohydrate/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 (monohydrate/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 (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1198 | 67046-1198-03 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1271 | 67046-1271-03 |
| Nitrofurantoin (Monohydrate/Macrocrystals) | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Creekwood Pharmaceuticals LLC | 82619-147 | 82619-0147-0182619-0147-0282619-0147-03 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7571 | 00904-7571-61 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4358 | 70518-4358-00 |
| NITROFURANTOIN (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-065 | 82868-0065-1082868-0065-1482868-0065-20 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4026 | 70518-4026-0070518-4026-0170518-4026-02+1 more |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8571 | 68788-8571-0068788-8571-01 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-196 | 72603-0196-01 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-606 | 68001-0606-00 |
Other NDCs under ANDA 217357
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 (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3569 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7571 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1198 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1271 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Redpharm Drug | 67296-2105 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-606 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3593 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8571 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4026 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4358 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2377 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-196 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Proficient Rx LP | 82804-115 |