Nitrofurantoin (monohydrate/macrocrystals)

Product NDC
21695-300
11-digit product format
216950300
Labeler code
21695
Product ID
21695-300_047e8b1b-8888-40b7-b593-434e92eb333c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA080043
Marketing category
ANDA
Marketing start
1970-11-25
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
E
Listing certified through
2017-12-31
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.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-300IInactivated by FDA2026-10-05
excluded packagepackage21695-30021695-300-14IInactivated by FDA2026-10-05
excluded packagepackage21695-30021695-300-20IInactivated by FDA2026-10-05

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-300-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-300-14d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-300-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-300-14f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-300-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-300-142ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-300-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-300-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-300-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-300-14cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-300-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-300-14cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-300-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-300-14302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-300-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-300-14ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-300-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-300-140efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-300-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-300-14ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-300-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-300-14367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-300-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-300-14557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-300-208af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-300-148af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-300-20834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-300-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-300-201332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-300-141332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-300-20fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-300-14fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-300-2086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-300-1486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-300-20bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-300-14bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-300-208dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-300-148dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-300-20e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-300-14e2bbac7714bc…27bdfed8d636…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080043-001NITROFURANTOINNITROFURANTOIN50MGTABLET / ORALApproved before 1982
A080043-002NITROFURANTOINNITROFURANTOIN100MGTABLET / ORALApproved before 1982

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080043-001NITROFURANTOIN50MGTABLET / ORALApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A080043-002NITROFURANTOIN100MGTABLET / ORALApproved before 198274a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-300-14Nitrofurantoin (monohydrate/macrocrystals)14 in 1 BOTTLECAPSULE141
21695-300-20Nitrofurantoin (monohydrate/macrocrystals)20 in 1 BOTTLECAPSULE201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-300-14EA - Each21695-300173fceff-65e4-445b-97de-9888172954c312012-07-24
21695-300-20EA - Each21695-3002320740d-93af-4f17-91f9-121b15beb78e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1
NITROFURANTOIN MONOHYDRATEACTIVE INGREDIENTE1QI2CQQ1INITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1
NITROFURANTOINACTIVE MOIETY927AH8112LNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-300NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110121_047e8b1b-8888-40b7-b593-434e92eb333c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN047e8b1b-8888-40b7-b593-434e92eb333c1
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD047e8b1b-8888-40b7-b593-434e92eb333c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-300-142169503001414 in 1 BOTTLEHistorical
21695-300-202169503002020 in 1 BOTTLEHistorical