Nitrofurantoin Macrocrystals
- Product NDC
- 68071-4681
- 11-digit product format
- 680714681
- Labeler code
- 68071
- Product ID
- 68071-4681_7df4ab0a-dbe3-8291-e053-2991aa0a3043
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin Macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA073652
- Marketing category
- ANDA
- Marketing start
- 2007-03-08
- Marketing end
- 0000-00-00
- Substance
- NITROFURANTOIN
- Active strength
- 100 mg/1
- Pharmacologic classes
- Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68071-4681 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 68071-4681 | 68071-4681-7 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A073652-001 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | 100MG | CAPSULE / ORAL | AB | 1993-01-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A073652-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A073652-001 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nitrofurantoin Macrocrystals | NITROFURANTOIN MACROCRYSTALS | PD-Rx Pharmaceuticals, Inc. | 536ed022-db80-492d-b6ab-809855ea90fb | 2026-07-17 | Warnings, Adverse reactions | 073652 ANDA073652 |
| Nitrofurantoin Macrocrystals | NITROFURANTOIN MACROCRYSTALS | Amneal Pharmaceuticals of New York LLC | 341c75ac-fba5-480d-a221-868c4195cb6f | 2026-04-14 | Warnings, Adverse reactions | 073652 ANDA073652 |
| Nitrofurantoin Macrocrystals | NITROFURANTOIN MACROCRYSTALS | AvPAK | 650f3c60-d45d-4358-a388-7efee4ad0497 | 2026-02-25 | Warnings, Adverse reactions | 073652 ANDA073652 |
| Nitrofurantoin Macrocrystals | NITROFURANTOIN MACROCRYSTALS | Redpharm Drug | 32520c80-0ce5-ea4b-e063-6294a90a37ba | 2025-12-18 | Warnings, Adverse reactions | 073652 ANDA073652 |
| Nitrofurantoin | NITROFURANTOIN MACROCRYSTALS | Bryant Ranch Prepack | c335f76b-6b85-4c9f-bbfa-95514cdd80fa | 2024-04-08 | Warnings, Adverse reactions | 073652 ANDA073652 |
| Nitrofurantoin Macrocrystals | NITROFURANTOIN MACROCRYSTALS | Proficient Rx LP | c87f65b9-14f7-4962-bff6-58b0d1af75f8 | 2020-01-01 | Warnings, Adverse reactions | 073652 ANDA073652 |