Nitrofurantoin
- Product NDC
- 0472-1992
- 11-digit product format
- 004721992
- Labeler code
- 0472
- Product ID
- 0472-1992_daa2705a-a5a4-407a-9333-8693d3afe00b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA205180
- Marketing category
- ANDA
- Marketing start
- 2016-10-07
- Marketing end
- 0000-00-00
- Substance
- NITROFURANTOIN
- Active strength
- 25 mg/5mL
- Pharmacologic classes
- Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 0472-1992 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0472-1992 | 0472-1992-08 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A205180-001 | NITROFURANTOIN | NITROFURANTOIN | 25MG/5ML | SUSPENSION / ORAL | AB | | 2016-05-03 |
Therapeutic equivalence codes#
Application-product, TE code table| Application-product | TE code |
|---|
| A205180-001 | AB |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0472-1992-08 | 00472199208 | 1 BOTTLE, GLASS in 1 CARTON (0472-1992-08) > 230 mL in 1 BOTTLE, GLASS | 2016-10-07 | 0000-00-00 | No | No | Current |