Nitrofurantoin

Product NDC
68788-8258
11-digit product format
687888258
Labeler code
68788
Product ID
68788-8258_1749c679-6cb0-4a4d-bdae-7e3406a46710
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208516
Marketing category
ANDA
Marketing start
2022-09-16
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
2027-12-31

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
729f6bbb-ab64-4b65-979a-4ad7605c5947Available 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
68788-8258-0Nitrofurantoin10 in 1 BOTTLECAPSULE105
68788-8258-1Nitrofurantoin14 in 1 BOTTLECAPSULE145
68788-8258-8Nitrofurantoin28 in 1 BOTTLECAPSULE285

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8258-0EA - Each68788-8258b29d5013-7e21-4ed3-833a-55cbd3c522aa12022-10-06
68788-8258-1EA - Each68788-82580b790a87-aac4-471e-8516-7b2cab49f0b712022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8258NITROFURANTOIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20240725_729f6bbb-ab64-4b65-979a-4ad7605c5947.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
ndc (product): 68788-8258
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
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 CapsulePSN729f6bbb-ab64-4b65-979a-4ad7605c59475
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD729f6bbb-ab64-4b65-979a-4ad7605c59475

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8258-06878882580010 CAPSULE in 1 BOTTLE (68788-8258-0) 10 capsule2022-09-160000-00-00NoNoCurrent
68788-8258-16878882580114 CAPSULE in 1 BOTTLE (68788-8258-1) 14 capsule2022-09-160000-00-00NoNoCurrent
68788-8258-86878882580828 CAPSULE in 1 BOTTLE (68788-8258-8) 28 capsule2023-08-15NoNoCurrent