Nitrofurantoin
- Product NDC
- 53002-7041
- Requested package NDC
- 53002-7041-4
- 11-digit product format
- 530027041
- Labeler code
- 53002
- Product ID
- 53002-7041_42f492a4-ff3d-4f8c-bb09-6e0eb3f6e57e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA077066
- Marketing category
- ANDA
- Marketing start
- 2005-04-06
- Marketing end
- 0000-00-00
- Substance
- NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
- Active strength
- 75 mg/1; mg/1
- Pharmacologic classes
- Nitrofurans [CS],Nitrofuran Antibacterial [EPC],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#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 53002-7041 | 53002-7041-4 | I | Inactivated by FDA | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077066-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077066-001 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 75MG;25MG | CAPSULE / ORAL | AB | 2005-04-05 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077066-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077066-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077066-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077066-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077066-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077066-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077066-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077066-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077066-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077066-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077066-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077066-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077066-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077066-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077066-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077066-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077066-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077066-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077066-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077066-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077066-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077066-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077066-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077066-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077066-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077066-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077066-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077066-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A077066-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A077066-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077066-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077066-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077066-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077066-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A077066-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A077066-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077066-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A077066-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A077066-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077066-001 | AB | 1 | cb3db0bc1861… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d02ec8bb-3b28-9b95-8719-8dbb1a2ec5cf | Product name | 6 | 20251106 |
| f6207266-e92b-4b5b-a91b-4af4215c9542 | Product name | 6 | 20240813 |
| e31776f7-6119-9577-e170-5b569993276e | Product name | 5 | 20240320 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-7041-1 | Nitrofurantoin | 6 in 1 BOTTLE | CAPSULE | 6 | 5 | |
| 53002-7041-2 | Nitrofurantoin | 10 in 1 BOTTLE | CAPSULE | 10 | 5 | |
| 53002-7041-3 | Nitrofurantoin | 14 in 1 BOTTLE | CAPSULE | 14 | 5 | |
| 53002-7041-4 | Nitrofurantoin | 20 in 1 BOTTLE | CAPSULE | 20 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-7041 | NITROFURANTOIN (NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)) CAPSULE [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 4 package rows | 20230609_393219f6-580c-4fc5-87c8-c8506380da7b.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | REMEDYREPACK INC. | ae892973-9ef4-4cf0-baf3-fbe158697bac | 2026-07-02 | Warnings, Adverse reactions | 077066 ANDA077066 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | St. Mary's Medical Park Pharmacy | 87210c87-b7db-0f65-e053-2a91aa0a4393 | 2026-06-07 | Warnings, Adverse reactions | 077066 ANDA077066 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Northwind Health Company, LLC | 0631d961-ef23-8f2a-e063-6294a90aa0a8 | 2026-01-26 | Warnings, Adverse reactions | 077066 ANDA077066 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | PD-Rx Pharmaceuticals, Inc. | 7767697f-4dd0-477d-b5cc-e1ed5689f097 | 2026-01-05 | Warnings, Adverse reactions | 077066 ANDA077066 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | PD-Rx Pharmaceuticals, Inc. | 643cdcff-8599-4326-b3ca-d9fd270e0fc2 | 2026-01-05 | Warnings, Adverse reactions | 077066 ANDA077066 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Northwind Health Company, LLC | 04b4189e-9b21-78ed-e063-6394a90ab8e0 | 2026-01-01 | Warnings, Adverse reactions | 077066 ANDA077066 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | QPharma, Inc. | fbc05ccb-782b-55f6-e053-6394a90a7fd6 | 2025-12-16 | Warnings, Adverse reactions | 077066 ANDA077066 |
| Nitrofurantoin | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | A-S Medication Solutions | b644426c-c8ba-4fe0-80c7-d9b2dde37395 | 2025-08-13 | Warnings, Adverse reactions | 077066 ANDA077066 |
| NITROFURANTOIN | NITROFURANTOIN | Directrx | d4385368-46d6-8397-e053-2a95a90a8d68 | 2025-01-17 | Warnings, Adverse reactions | 077066 ANDA077066 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NuCare Pharmaceuticals,Inc. | 68a651f9-1aef-792e-e053-2991aa0a3cbb | 2024-12-30 | Warnings, Adverse reactions | 077066 ANDA077066 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NuCare Pharmaceuticals,Inc. | 6bccbaab-151b-4a04-e053-2991aa0ae105 | 2024-06-10 | Warnings, Adverse reactions | 077066 ANDA077066 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Sandoz Inc | 7ba9a729-a73a-4a13-a336-0284cc8a67e1 | 2024-02-28 | Warnings, Adverse reactions | 077066 ANDA077066 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Bryant Ranch Prepack | 05f4b126-0fb9-5ee9-c89c-f229e60f84e3 | 2023-11-09 | Warnings, Adverse reactions | 077066 ANDA077066 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Asclemed USA, Inc. | 1ab658f0-021a-46a1-bff3-d3334c23442d | 2022-09-21 | Warnings, Adverse reactions | 077066 ANDA077066 |
| Nitrofurantoin (monohydrate/macrocrystals) | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Proficient Rx LP | d802d734-dc8f-4f3c-bce6-aaccc4614c89 | 2022-09-01 | Warnings, Adverse reactions | 077066 ANDA077066 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1648755 | nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule | PSN | 393219f6-580c-4fc5-87c8-c8506380da7b | 5 |
| 1648755 | nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule | SCD | 393219f6-580c-4fc5-87c8-c8506380da7b | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-7041-4 | 53002704104 | 20 CAPSULE in 1 BOTTLE (53002-7041-4) | 20 capsule | 2017-10-01 | 0000-00-00 | No | No | Current |