Prescription drug · ANDA
Nitrofurantoin NDC 68071-2928
Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 · Capsule · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68071-2928Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-2928Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-2928-1 | 6807129280168071292801 | 10 CAPSULE in 1 BOTTLE (68071-2928-1)Marketed from Feb 6, 2023 | |
| 68071-2928-2 | 6807129280268071292802 | 20 CAPSULE in 1 BOTTLE (68071-2928-2)Marketed from Feb 6, 2023 | |
| 68071-2928-4 | 6807129280468071292804 | 14 CAPSULE in 1 BOTTLE (68071-2928-4)Marketed from Feb 6, 2023 | |
| 68071-2928-6 | 6807129280668071292806 | 6 CAPSULE in 1 BOTTLE (68071-2928-6)Marketed from Feb 6, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Generic name (nonproprietary)
- nitrofurantoin
- Active ingredients
- Nitrofurantoin — 25 mg/1Nitrofurantoin monohydrate — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208516
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)Nitrofurans (Chemical structure)
- Identifiers
- Product ID 68071-2928_5c194601-e752-5395-e063-6394a90abc4bSPL ID 5c194601-e752-5395-e063-6394a90abc4b
- 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
N468071292801followed by a unit qualifier and the quantityPackage 68071-2928-01. 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 68071-2928
- What is NDC 68071-2928?
- 68071-2928 is the product NDC for Nitrofurantoin, Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 capsule, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitrofurantoin.
- What is the active ingredient?
- Nitrofurantoin, Nitrofurantoin monohydrate.
- Who is the labeler?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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?
- 43 other product NDCs are listed under this name. See all Nitrofurantoin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nitrofurantoin 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 | Nitrofurantoin 25 mg/5mL | SuspensionOral | Camber Pharmaceuticals, Inc. | 31722-491 | 31722-0491-23 |
| Nitrofurantoin | Nitrofurantoin 25 mg/5mL | For suspensionOral | Somerset Therapeutics, LLC | 70069-829 | 70069-0829-01 |
| Nitrofurantoin | Nitrofurantoin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4244 | 70518-4244-00 |
| Nitrofurantoin | Nitrofurantoin 25 mg/5mL | SuspensionOral | Biocon Pharma Inc | 70377-118 | 70377-0118-31 |
| Nitrofurantoin | Nitrofurantoin 100 mg/1 | CapsuleOral | Micro Labs Limited | 42571-393 | 42571-0393-0142571-0393-0542571-0393-90 |
| Nitrofurantoin | Nitrofurantoin 50 mg/5mL | SuspensionOral | Rising Pharma Holdings, Inc. | 16571-888 | 16571-0888-06 |
| nitrofurantoinnitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7217 | 50090-7217-0050090-7217-0250090-7217-03 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-853 | 60760-0853-14 |
| Nitrofurantoinnitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3569 | 68071-3569-0168071-3569-0268071-3569-04 |
| Nitrofurantoin | Nitrofurantoin monohydrate 25 mg/5mL | SuspensionOral | Aurobindo Pharma Limited | 59651-206 | 59651-0206-23 |
Other NDCs under ANDA 208516
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 |
|---|---|---|---|---|
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Trigen Laboratories, LLC | 13811-719 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-853 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2464 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Redpharm Drug, Inc. | 67296-1442 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8258 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3717 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-852 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2255 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2320 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2914 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1262 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-386 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-387 |
| Nitrofurantoin Monohydrate/Macrocrystal | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Direct_Rx | 72189-395 |