Nitrofurantoin (monohydrate/macrocrystals)

Product NDC
70756-404
Requested package NDC
70756-404-51
11-digit product format
707560404
Labeler code
70756
Product ID
70756-404_03bd4661-52d3-4e0c-a70f-bfb3f286df78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA217357
Marketing category
ANDA
Marketing start
2023-09-14
Substance
NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
Active strength
75; 25 mg/1; mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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

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
A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE75MG;25MGCAPSULE / ORALAB2023-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217357-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-1184e616aacf4f…
2026-08-18 06:07:402026-07A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-118072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-11a67488948f0b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217357-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2023-07-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217357-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A217357-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217357-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217357-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217357-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217357-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217357-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217357-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217357-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217357-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217357-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217357-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217357-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217357-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217357-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217357-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217357-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217357-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217357-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217357-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217357-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217357-001AB1a67488948f0b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217357-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Nitrofurantoin (monohydrate/macrocrystals)
Listing expiration
2027-12-31

Active Ingredients#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-404-11Nitrofurantoin (monohydrate/macrocrystals)100 in 1 BOTTLECAPSULE1004
70756-404-51Nitrofurantoin (monohydrate/macrocrystals)500 in 1 BOTTLECAPSULE5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-404NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [LIFESTAR PHARMA LLC]4Current NDC, 2 package rows20230914_35c0a6d8-ff85-4d9b-9ad3-ae20808119dd.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
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)REMEDYREPACK INC.4553ccc1-0bad-4c75-aae2-1a1c87bc8db02026-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217357
application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)REMEDYREPACK INC.e55f3dc2-c754-4550-a2c0-c304471a87912026-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217357
application number: ANDA217357
NitrofurantoinNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NuCare Pharmaceuticals,Inc.10e2503d-a250-996f-e063-6294a90abd612026-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217357
application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)BluePoint Laboratoriesea28d766-d6e6-43d2-8282-dc78a03810572026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217357
application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Coupler LLC513b514f-6e79-f187-e063-6394a90a07dc2026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217357
application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Coupler LLC5087f071-5ef4-753e-e063-6294a90afb8d2026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217357
application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Major Pharmaceuticals85c7d4ee-99f5-4324-a5fa-601c2fe664ab2026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217357
application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Redpharm Drug18987b15-6554-6b55-e063-6294a90a58d42026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217357
application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Preferred Pharmaceuticals Inc.11e8f91c-5712-4267-9956-e619d081d1f42026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217357
application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NuCare Pharmaceuticals,Inc.155c8d68-576e-f85c-e063-6294a90ada4b2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217357
application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Bryant Ranch Prepack63a4b367-bf4b-4b5f-b3e9-394ba307886d2025-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217357
application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Proficient Rx LPf49f586a-79f0-4731-97f9-9aeb0839ece52024-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217357
application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NorthStar RxLLCd1c778b5-70df-4312-976b-d0bca0cb602a2023-10-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217357
application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Lifestar Pharma LLC35c0a6d8-ff85-4d9b-9ad3-ae20808119dd2023-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217357
application number: ANDA217357
ndc (package): 70756-404-51
ndc (product): 70756-404
ndc11 (package): 70756040451

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNe55f3dc2-c754-4550-a2c0-c304471a87916
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDe55f3dc2-c754-4550-a2c0-c304471a87916
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNf49f586a-79f0-4731-97f9-9aeb0839ece54
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN35c0a6d8-ff85-4d9b-9ad3-ae20808119dd4
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDf49f586a-79f0-4731-97f9-9aeb0839ece54
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD35c0a6d8-ff85-4d9b-9ad3-ae20808119dd4
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN18987b15-6554-6b55-e063-6294a90a58d43
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN63a4b367-bf4b-4b5f-b3e9-394ba307886d3
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD63a4b367-bf4b-4b5f-b3e9-394ba307886d3
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD18987b15-6554-6b55-e063-6294a90a58d43
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN10e2503d-a250-996f-e063-6294a90abd612
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN155c8d68-576e-f85c-e063-6294a90ada4b2
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN11e8f91c-5712-4267-9956-e619d081d1f42
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD155c8d68-576e-f85c-e063-6294a90ada4b2
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD11e8f91c-5712-4267-9956-e619d081d1f42
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD10e2503d-a250-996f-e063-6294a90abd612
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN513b514f-6e79-f187-e063-6394a90a07dc1
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN85c7d4ee-99f5-4324-a5fa-601c2fe664ab1
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD513b514f-6e79-f187-e063-6394a90a07dc1
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD85c7d4ee-99f5-4324-a5fa-601c2fe664ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-404-5170756040451500 CAPSULE in 1 BOTTLE (70756-404-51) 500 capsule2023-09-14NoNoCurrent