Prescription drug · ANDA
nitrofurantoin (Nitrofurantoin macrocrystals) NDC 71335-1069
Nitrofurantoin 100 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1069-1 | 7133510690171335106901 | 40 CAPSULE in 1 BOTTLE (71335-1069-1)Marketed from May 17, 2024 | |
| 71335-1069-2 | 7133510690271335106902 | 28 CAPSULE in 1 BOTTLE (71335-1069-2)Marketed from May 17, 2024 | |
| 71335-1069-3 | 7133510690371335106903 | 30 CAPSULE in 1 BOTTLE (71335-1069-3)Marketed from May 17, 2024 | |
| 71335-1069-4 | 7133510690471335106904 | 20 CAPSULE in 1 BOTTLE (71335-1069-4)Marketed from May 17, 2024 | |
| 71335-1069-5 | 7133510690571335106905 | 14 CAPSULE in 1 BOTTLE (71335-1069-5)Marketed from Jan 21, 2019 | |
| 71335-1069-6 | 7133510690671335106906 | 10 CAPSULE in 1 BOTTLE (71335-1069-6)Marketed from Feb 25, 2019 | |
| 71335-1069-7 | 7133510690771335106907 | 12 CAPSULE in 1 BOTTLE (71335-1069-7)Marketed from May 17, 2024 | |
| 71335-1069-8 | 7133510690871335106908 | 90 CAPSULE in 1 BOTTLE (71335-1069-8)Marketed from May 17, 2024 | |
| 71335-1069-9 | 7133510690971335106909 | 6 CAPSULE in 1 BOTTLE (71335-1069-9)Marketed from May 17, 2024 |
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 macrocrystals
- Active ingredients
- Nitrofurantoin — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- 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 71335-1069_05e89273-b886-40bb-be42-7807d29f5deeSPL ID 05e89273-b886-40bb-be42-7807d29f5deeSPL set ID aca04d52-8a64-4fca-94b2-64b46f5a3218RxCUI 1648759UNII 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
N471335106901followed by a unit qualifier and the quantityPackage 71335-1069-01. 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
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 71335-1069
- What is NDC 71335-1069?
- 71335-1069 is the product NDC for nitrofurantoin (nitrofurantoin macrocrystals), Nitrofurantoin 100 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 9 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- nitrofurantoin (Nitrofurantoin macrocrystals).
- What is the active ingredient?
- Nitrofurantoin.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 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 |
|---|---|---|---|---|
| nitrofurantoin macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7026 |
| 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 |