Nitrofurantion

Product NDC
68071-2363
11-digit product format
680712363
Labeler code
68071
Product ID
68071-2363_4b353a66-abe4-a233-e063-6294a90a685d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantion
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA201722
Marketing category
ANDA
Marketing start
2016-04-15
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2363-80efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2363-70efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-2363-8ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-2363-7ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-2363-8367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-2363-7367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-2363-8557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-2363-7557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-2363-88af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-2363-78af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-2363-8834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-2363-7834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-2363-81332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-2363-71332a3947898…d4bfe170f9cd…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201722-001NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINE25MGCAPSULE / ORAL2016-02-16
A201722-002NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINE50MGCAPSULE / ORAL2016-02-16
A201722-003NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINE100MGCAPSULE / ORAL2016-02-16

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A201722-001NITROFURANTOIN25MGCAPSULE / ORAL2016-02-16caaa826d4ba7…
2026-08-18 06:07:402026-07A201722-002NITROFURANTOIN50MGCAPSULE / ORAL2016-02-16caaa826d4ba7…
2026-08-18 06:07:402026-07A201722-003NITROFURANTOIN100MGCAPSULE / ORAL2016-02-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201722-001NITROFURANTOIN25MGCAPSULE / ORAL2016-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201722-002NITROFURANTOIN50MGCAPSULE / ORAL2016-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201722-003NITROFURANTOIN100MGCAPSULE / ORAL2016-02-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201722-001NITROFURANTOIN25MGCAPSULE / ORALAB2016-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201722-002NITROFURANTOIN50MGCAPSULE / ORALAB2016-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201722-003NITROFURANTOIN100MGCAPSULE / ORALAB2016-02-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A201722-001NITROFURANTOIN25MGCAPSULE / ORALAB2016-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201722-002NITROFURANTOIN50MGCAPSULE / ORALAB2016-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201722-003NITROFURANTOIN100MGCAPSULE / ORALAB2016-02-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201722-001NITROFURANTOIN25MGCAPSULE / ORALAB2016-02-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201722-002NITROFURANTOIN50MGCAPSULE / ORALAB2016-02-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201722-003NITROFURANTOIN100MGCAPSULE / ORALAB2016-02-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201722-001NITROFURANTOIN25MGCAPSULE / ORALAB2016-02-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201722-002NITROFURANTOIN50MGCAPSULE / ORALAB2016-02-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201722-003NITROFURANTOIN100MGCAPSULE / ORALAB2016-02-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201722-001NITROFURANTOIN25MGCAPSULE / ORALAB2016-02-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201722-002NITROFURANTOIN50MGCAPSULE / ORALAB2016-02-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201722-003NITROFURANTOIN100MGCAPSULE / ORALAB2016-02-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201722-001NITROFURANTOIN25MGCAPSULE / ORALAB2016-02-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201722-002NITROFURANTOIN50MGCAPSULE / ORALAB2016-02-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201722-003NITROFURANTOIN100MGCAPSULE / ORALAB2016-02-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201722-001NITROFURANTOIN25MGCAPSULE / ORALAB2016-02-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201722-002NITROFURANTOIN50MGCAPSULE / ORALAB2016-02-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201722-003NITROFURANTOIN100MGCAPSULE / ORALAB2016-02-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201722-001NITROFURANTOIN25MGCAPSULE / ORALAB2016-02-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201722-002NITROFURANTOIN50MGCAPSULE / ORALAB2016-02-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201722-003NITROFURANTOIN100MGCAPSULE / ORALAB2016-02-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201722-001NITROFURANTOIN25MGCAPSULE / ORALAB2016-02-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A201722-002NITROFURANTOIN50MGCAPSULE / ORALAB2016-02-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A201722-003NITROFURANTOIN100MGCAPSULE / ORALAB2016-02-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201722-001NITROFURANTOIN25MGCAPSULE / ORALAB2016-02-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201722-002NITROFURANTOIN50MGCAPSULE / ORALAB2016-02-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201722-003NITROFURANTOIN100MGCAPSULE / ORALAB2016-02-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201722-001NITROFURANTOIN25MGCAPSULE / ORALAB2016-02-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201722-002NITROFURANTOIN50MGCAPSULE / ORALAB2016-02-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201722-003NITROFURANTOIN100MGCAPSULE / ORALAB2016-02-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201722-001NITROFURANTOIN25MGCAPSULE / ORALAB2016-02-161e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201722-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201722-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201722-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201722-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201722-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201722-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201722-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201722-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201722-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201722-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201722-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201722-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201722-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201722-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201722-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201722-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201722-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201722-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201722-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201722-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201722-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201722-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201722-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201722-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201722-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201722-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201722-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201722-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201722-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201722-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201722-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201722-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201722-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201722-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201722-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201722-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201722-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201722-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201722-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201722-001AB15c6f7cd8ea54…

Additional Listing Data#

Finished product
Yes
Brand name base
Nitrofurantion
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1648759Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bd46cc46-0efa-d5d9-e053-2995a90a18f1Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2363-7Nitrofurantion14 in 1 BOTTLECAPSULE143
68071-2363-8Nitrofurantion28 in 1 BOTTLECAPSULE283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2363NITROFURANTION CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 2 package rows20250112_bd46cc46-0efa-d5d9-e053-2995a90a18f1.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitrofurantionNITROFURANTIONBryant Ranch Prepackeeb12928-61ab-42a0-a1fa-2819b9ffa3cb2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201722
application number: ANDA201722
NitrofurantionNITROFURANTIONSun Pharmaceutical Industries, Inc.05f25774-f56a-48ef-bac3-8af663f8581a2026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201722
application number: ANDA201722
NitrofurantionNITROFURANTIONNuCare Pharmaceuticals,Inc.bd46cc46-0efa-d5d9-e053-2995a90a18f12026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201722
application number: ANDA201722
ndc (product): 68071-2363
NitrofurantionNITROFURANTIONA-S Medication Solutions43848e61-4d94-46f7-a610-93be927c8d162023-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201722
application number: ANDA201722
NitrofurantionNITROFURANTIONProficient Rx LP870f64ca-0256-4e3f-8c34-dc603ccc41c02022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201722
application number: ANDA201722
NitrofurantionNITROFURANTIONBluePoint Labortoriesad020393-1c97-49da-b0f3-d6a9359fb73d2019-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201722
application number: ANDA201722

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSNbd46cc46-0efa-d5d9-e053-2995a90a18f13
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCDbd46cc46-0efa-d5d9-e053-2995a90a18f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2363-76807123630714 CAPSULE in 1 BOTTLE (68071-2363-7) 14 capsule2021-03-110000-00-00NoNoCurrent
68071-2363-86807123630828 CAPSULE in 1 BOTTLE (68071-2363-8) 28 capsule2021-03-110000-00-00NoNoCurrent