Nitrofurantoin

Product NDC
63629-2464
11-digit product format
636292464
Labeler code
63629
Product ID
63629-2464_fc71d17e-601d-48b1-aee8-ae1cf1fcdd5a
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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208516-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2018-05-24cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208516-001AB1cb3db0bc1861…

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
bebbe5d6-f6ec-4191-bad3-b6e933da0688Available 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
63629-2464-1Nitrofurantoin100 in 1 BOTTLECAPSULE100111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2464-1EA - Each63629-2464314d3428-f497-4c5d-8e66-39090420fa3612021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2464NITROFURANTOIN CAPSULE [BRYANT RANCH PREPACK]111Current NDC, Legacy NDC, 1 package rows20240806_bebbe5d6-f6ec-4191-bad3-b6e933da0688.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ndc (product): 63629-2464
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 CapsulePSNbebbe5d6-f6ec-4191-bad3-b6e933da0688111
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDbebbe5d6-f6ec-4191-bad3-b6e933da0688111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2464-163629246401100 CAPSULE in 1 BOTTLE (63629-2464-1) 100 capsule2022-08-310000-00-00NoNoCurrent