Nitrofurantoin

Product NDC
71335-2255
11-digit product format
713352255
Labeler code
71335
Product ID
71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208516
Marketing category
ANDA
Marketing start
2018-01-01
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25; 75 mg/1; mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE75MG;25MGCAPSULE / ORALAB2018-05-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A208516-001AB

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 06:07:402026-07A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-243f01610625f2…
2019-09-15 20:21 UTC2019-09A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208516-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208516-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208516-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208516-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208516-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208516-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208516-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208516-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208516-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208516-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208516-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208516-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208516-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208516-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208516-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208516-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208516-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208516-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208516-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208516-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208516-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208516-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208516-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208516-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208516-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208516-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208516-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208516-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208516-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208516-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208516-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208516-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208516-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208516-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208516-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208516-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208516-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208516-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208516-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208516-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Nitrofurantoin
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
927AH8112LInternal UNII lookup
E1QI2CQQ1IInternal 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
b807bd48-71ab-4578-b1d7-4d3260bf6c75Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2255-1Nitrofurantoin40 in 1 BOTTLECAPSULE40100
71335-2255-2Nitrofurantoin28 in 1 BOTTLECAPSULE28100
71335-2255-3Nitrofurantoin30 in 1 BOTTLECAPSULE30100
71335-2255-4Nitrofurantoin20 in 1 BOTTLECAPSULE20100
71335-2255-5Nitrofurantoin14 in 1 BOTTLECAPSULE14100
71335-2255-6Nitrofurantoin10 in 1 BOTTLECAPSULE10100
71335-2255-7Nitrofurantoin12 in 1 BOTTLECAPSULE12100
71335-2255-8Nitrofurantoin90 in 1 BOTTLECAPSULE90100
71335-2255-9Nitrofurantoin6 in 1 BOTTLECAPSULE6100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2255NITROFURANTOIN CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 9 package rows20231004_b807bd48-71ab-4578-b1d7-4d3260bf6c75.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitrofurantoinNITROFURANTOINNuCare Pharmaceuticals,Inc.f40af3e1-e54c-3a35-e053-2a95a90a6cb22026-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208516
application number: ANDA208516
NitrofurantoinNITROFURANTOINPreferred Pharmaceuticals Inc.729f6bbb-ab64-4b65-979a-4ad7605c59472026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208516
application number: ANDA208516
NitrofurantoinNITROFURANTOINSt. Mary's Medical Park Pharmacy09944470-807d-ad37-e063-6394a90a7bfe2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208516
application number: ANDA208516
NitrofurantoinNITROFURANTOINREMEDYREPACK INC.6c82b95d-2c32-4e54-a8a9-a4bb4df70cb52026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208516
application number: ANDA208516
NitrofurantoinNITROFURANTOINBryant Ranch Prepack1c5db054-58af-4932-8fad-c3883b13f9872025-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208516
application number: ANDA208516
NitrofurantoinNITROFURANTOINPD-Rx Pharmaceuticals, Inc.d88348a0-6ab4-4490-9325-1f14a541b0a52025-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208516
application number: ANDA208516
NitrofurantoinNITROFURANTOINPD-Rx Pharmaceuticals, Inc.37606c6f-0d85-4314-94ae-f7732c7bc8d52025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208516
application number: ANDA208516
NitrofurantoinNITROFURANTOINRedpharm Drug, Inc.f4c2c01d-bef7-3e5d-e053-2995a90ae0d82025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208516
application number: ANDA208516
NitrofurantoinNITROFURANTOINBryant Ranch Prepack56e07ad3-7224-4aaf-9a68-0d48d4abfec82024-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208516
application number: ANDA208516
Nitrofurantoin Monohydrate/MacrocrystalNITROFURANTOIN MONOHYDRATE/MACROCRYSTALDirect_Rxee13cf2a-cde0-8ab8-e053-2a95a90a9dda2024-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208516
application number: ANDA208516
NitrofurantoinNITROFURANTOINBryant Ranch Prepackbebbe5d6-f6ec-4191-bad3-b6e933da06882024-03-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208516
application number: ANDA208516
NitrofurantoinNITROFURANTOINBryant Ranch Prepack75dab97e-59b4-447c-a8c9-b4d5a970098f2024-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208516
application number: ANDA208516
NitrofurantoinNITROFURANTOINBryant Ranch Prepackb807bd48-71ab-4578-b1d7-4d3260bf6c752023-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208516
application number: ANDA208516
ndc (product): 71335-2255
NitrofurantoinNITROFURANTOINTrigen Laboratories, LLC39ffb8c6-4dd8-4436-b857-7306c15f662a2023-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208516
application number: ANDA208516
NitrofurantoinNITROFURANTOINProficient Rx LP34d3c103-27b8-454b-9f38-c33157c3b6fc2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208516
application number: ANDA208516

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNb807bd48-71ab-4578-b1d7-4d3260bf6c75100
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDb807bd48-71ab-4578-b1d7-4d3260bf6c75100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2255-17133522550140 CAPSULE in 1 BOTTLE (71335-2255-1) 40 capsule2023-10-02NoNoCurrent
71335-2255-27133522550228 CAPSULE in 1 BOTTLE (71335-2255-2) 28 capsule2023-10-02NoNoCurrent
71335-2255-37133522550330 CAPSULE in 1 BOTTLE (71335-2255-3) 30 capsule2023-10-02NoNoCurrent
71335-2255-47133522550420 CAPSULE in 1 BOTTLE (71335-2255-4) 20 capsule2023-10-02NoNoCurrent
71335-2255-57133522550514 CAPSULE in 1 BOTTLE (71335-2255-5) 14 capsule2023-10-02NoNoCurrent
71335-2255-67133522550610 CAPSULE in 1 BOTTLE (71335-2255-6) 10 capsule2023-10-02NoNoCurrent
71335-2255-77133522550712 CAPSULE in 1 BOTTLE (71335-2255-7) 12 capsule2023-10-02NoNoCurrent
71335-2255-87133522550890 CAPSULE in 1 BOTTLE (71335-2255-8) 90 capsule2023-10-02NoNoCurrent
71335-2255-9713352255096 CAPSULE in 1 BOTTLE (71335-2255-9) 6 capsule2023-10-02NoNoCurrent