Nitrofurantoin

Product NDC
65162-478
11-digit product format
651620478
Labeler code
65162
Product ID
65162-478_12c7ce84-65f3-4970-bdaf-b3c169294561
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin monohydrate/macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA207372
Marketing category
ANDA
Marketing start
2017-05-25
Marketing end
0000-00-00
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25 mg/1; mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE75MG;25MGCAPSULE / ORAL2017-05-15

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2017-05-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2017-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2017-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORAL2017-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-153f01610625f2…
2019-09-15 20:21 UTC2019-09A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207372-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2017-05-15e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207372-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207372-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207372-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207372-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207372-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207372-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207372-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207372-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207372-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207372-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207372-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207372-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207372-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207372-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207372-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207372-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207372-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207372-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207372-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207372-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207372-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207372-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207372-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207372-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207372-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207372-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207372-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207372-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207372-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207372-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207372-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207372-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207372-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207372-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207372-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207372-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207372-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Nitrofurantoin
Brand name suffix
(monohydrate/macrocrystals)

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN MONOHYDRATE75 mg/1
NITROFURANTOIN25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E1QI2CQQ1IInternal UNII lookup
927AH8112LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1648755Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55c75f27-b5fc-4f19-8607-08f8ec0c69ecAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d02ec8bb-3b28-9b95-8719-8dbb1a2ec5cfProduct name620251106
f6207266-e92b-4b5b-a91b-4af4215c9542Product name620240813
e31776f7-6119-9577-e170-5b569993276eProduct name520240320
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-478-10EA - Each65162-47866e24d50-1051-4173-b73c-2544c9733c5e12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-478NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS) CAPSULE [AMNEAL PHARMACEUTICALS LLC]19Legacy NDC20241031_55c75f27-b5fc-4f19-8607-08f8ec0c69ec.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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN MONOHYDRATE/MACROCRYSTALSAmneal Pharmaceuticals LLC55c75f27-b5fc-4f19-8607-08f8ec0c69ec2024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207372
application number: ANDA207372
ndc (product): 65162-478

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN58614369-f5ac-4d38-9fb8-2383b791eb715
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD58614369-f5ac-4d38-9fb8-2383b791eb715
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN0f4d7699-d5d8-4c36-aaa6-63c3c8c68b4f3
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN2bedff75-22c8-49cf-b2e6-8471fd69055c3
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD0f4d7699-d5d8-4c36-aaa6-63c3c8c68b4f3
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD2bedff75-22c8-49cf-b2e6-8471fd69055c3
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN88de4809-bcbd-02ab-e053-2a95a90a4e882
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD88de4809-bcbd-02ab-e053-2a95a90a4e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-478-1065162047810100 CAPSULE in 1 BOTTLE (65162-478-10) 100 capsule2017-05-250000-00-00NoNoCurrent