Nitrofurantoin Macrocrystals
- Product NDC
- 70934-217
- 11-digit product format
- 709340217
- Labeler code
- 70934
- Product ID
- 70934-217_ada4da62-1ec5-758d-e053-2995a90a2fef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin Macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. dba Northwind Pharmaceuticals
- Application
- ANDA073652
- Marketing category
- ANDA
- Marketing start
- 2018-12-19
- 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
- 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. 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 | 70934-217 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 70934-217 | 70934-217-10 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 70934-217 | 70934-217-14 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A073652-001 | NITROFURANTOIN | 100MG | CAPSULE / ORAL | AB | 1993-01-28 | cb3db0bc1861… | |
| 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 |
|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073652-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073652-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A073652-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073652-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A073652-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A073652-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A073652-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A073652-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A073652-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A073652-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A073652-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A073652-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A073652-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A073652-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A073652-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A073652-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A073652-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A073652-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A073652-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A073652-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A073652-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A073652-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A073652-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A073652-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A073652-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A073652-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A073652-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A073652-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A073652-001 | AB | 1 | cb3db0bc1861… |
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70934-217-10 | 2023-02-03 | C162847 | 48780-1 | d6a99b39-fdfe-a426-e053-dadaa90af4c2 | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
| 70934-217-14 | 2023-02-03 | C162847 | 48780-1 | d6a99b39-fdfe-a426-e053-dadaa90af4c2 | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
| 70934-217-10 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-fdfe-a426-e053-dadaa90af4c2 | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
| 70934-217-14 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-fdfe-a426-e053-dadaa90af4c2 | NITROFURANTOIN CAPSULES, USP (Macrocrystals) 50 mg and 100 mg Rx only |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70934-217-10 | 70934021710 | 10 CAPSULE in 1 BOTTLE, PLASTIC (70934-217-10) | 10 capsule | 2020-03-05 | 0000-00-00 | No | No | Current |
| 70934-217-14 | 70934021714 | 14 CAPSULE in 1 BOTTLE, PLASTIC (70934-217-14) | 14 capsule | 2018-12-19 | 0000-00-00 | No | No | Current |