Prescription drug · ANDA
Nitrofurantoin (Monohydrate/Macrocrystals) NDC 82619-147
Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 · Capsule · Oral · Creekwood Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82619-147-01 | 8261901470182619014701 | 100 CAPSULE in 1 BOTTLE (82619-147-01)Marketed from Apr 20, 2026 | |
| 82619-147-02 | 8261901470282619014702 | 500 CAPSULE in 1 BOTTLE (82619-147-02)Marketed from Apr 20, 2026 | |
| 82619-147-03 | 8261901470382619014703 | 1 BLISTER PACK in 1 CARTON (82619-147-03) / 14 CAPSULE in 1 BLISTER PACKMarketed from Apr 20, 2026 |
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 — 25 mg/1Nitrofurantoin monohydrate — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Creekwood Pharmaceuticals LLCNDC labeler code 82619
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220269
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)Nitrofurans (Chemical structure)
- Identifiers
- Product ID 82619-147_4f67eeb9-5a7a-3693-e063-6394a90a8655SPL ID 4f67eeb9-5a7a-3693-e063-6394a90a8655SPL set ID e47175a3-68a2-4084-9c0e-96fb057448bfRxCUI 1648755UNII 927AH8112L, E1QI2CQQ1IUPC 0382619147025, 0382619147018, 0382619147032
- 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
N482619014701followed by a unit qualifier and the quantityPackage 82619-0147-01. 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 capsules (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus . 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 capsules (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteri…
Excerpt only. Read the full label for complete information.
About NDC 82619-147
- What is NDC 82619-147?
- 82619-147 is the product NDC for Nitrofurantoin (Monohydrate/Macrocrystals), Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 capsule, listed with the FDA by Creekwood Pharmaceuticals LLC. It has 3 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, Nitrofurantoin monohydrate.
- Who is the labeler?
- Creekwood Pharmaceuticals LLC, NDC labeler code 82619. 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 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 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-012 | 82868-0012-14 |