nitrofurantoin macrocrystals

Product NDC
71335-2212
11-digit product format
713352212
Labeler code
71335
Product ID
71335-2212_286e68d4-754d-4900-9365-901ecccac6b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitrofurantoin macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217272
Marketing category
ANDA
Marketing start
2023-03-21
Substance
NITROFURANTOIN
Active strength
100 mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217272-001NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINE25MGCAPSULE / ORALAB2023-03-21
A217272-002NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINE50MGCAPSULE / ORALAB2023-03-21
A217272-003NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINE100MGCAPSULE / ORALAB2023-03-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A217272-001AB
A217272-002AB
A217272-003AB

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 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A217272-001NITROFURANTOIN25MGCAPSULE / ORALAB2023-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A217272-002NITROFURANTOIN50MGCAPSULE / ORALAB2023-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A217272-003NITROFURANTOIN100MGCAPSULE / ORALAB2023-03-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217272-001NITROFURANTOIN25MGCAPSULE / ORALAB2023-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217272-002NITROFURANTOIN50MGCAPSULE / ORALAB2023-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217272-003NITROFURANTOIN100MGCAPSULE / ORALAB2023-03-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217272-001NITROFURANTOIN25MGCAPSULE / ORALAB2023-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217272-002NITROFURANTOIN50MGCAPSULE / ORALAB2023-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217272-003NITROFURANTOIN100MGCAPSULE / ORALAB2023-03-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217272-001NITROFURANTOIN25MGCAPSULE / ORALAB2023-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217272-002NITROFURANTOIN50MGCAPSULE / ORALAB2023-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217272-003NITROFURANTOIN100MGCAPSULE / ORALAB2023-03-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217272-001NITROFURANTOIN25MGCAPSULE / ORALAB2023-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217272-002NITROFURANTOIN50MGCAPSULE / ORALAB2023-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217272-003NITROFURANTOIN100MGCAPSULE / ORALAB2023-03-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217272-001NITROFURANTOIN25MGCAPSULE / ORALAB2023-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217272-002NITROFURANTOIN50MGCAPSULE / ORALAB2023-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217272-003NITROFURANTOIN100MGCAPSULE / ORALAB2023-03-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217272-001NITROFURANTOIN25MGCAPSULE / ORALAB2023-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217272-002NITROFURANTOIN50MGCAPSULE / ORALAB2023-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217272-003NITROFURANTOIN100MGCAPSULE / ORALAB2023-03-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217272-001NITROFURANTOIN25MGCAPSULE / ORALAB2023-03-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217272-002NITROFURANTOIN50MGCAPSULE / ORALAB2023-03-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217272-003NITROFURANTOIN100MGCAPSULE / ORALAB2023-03-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217272-001NITROFURANTOIN25MGCAPSULE / ORALAB2023-03-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217272-002NITROFURANTOIN50MGCAPSULE / ORALAB2023-03-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217272-003NITROFURANTOIN100MGCAPSULE / ORALAB2023-03-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217272-001NITROFURANTOIN25MGCAPSULE / ORALAB2023-03-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217272-002NITROFURANTOIN50MGCAPSULE / ORALAB2023-03-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217272-003NITROFURANTOIN100MGCAPSULE / ORALAB2023-03-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217272-001NITROFURANTOIN25MGCAPSULE / ORALAB2023-03-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A217272-002NITROFURANTOIN50MGCAPSULE / ORALAB2023-03-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A217272-003NITROFURANTOIN100MGCAPSULE / ORALAB2023-03-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217272-001NITROFURANTOIN25MGCAPSULE / ORALAB2023-03-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217272-002NITROFURANTOIN50MGCAPSULE / ORALAB2023-03-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217272-003NITROFURANTOIN100MGCAPSULE / ORALAB2023-03-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217272-001NITROFURANTOIN25MGCAPSULE / ORALAB2023-03-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217272-002NITROFURANTOIN50MGCAPSULE / ORALAB2023-03-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217272-003NITROFURANTOIN100MGCAPSULE / ORALAB2023-03-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217272-001NITROFURANTOIN25MGCAPSULE / ORALAB2023-03-211e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217272-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217272-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217272-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217272-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217272-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217272-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217272-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217272-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217272-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217272-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217272-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217272-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217272-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217272-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217272-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217272-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217272-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217272-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217272-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217272-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217272-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217272-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217272-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217272-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217272-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217272-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217272-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217272-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217272-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217272-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217272-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217272-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217272-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217272-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217272-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217272-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217272-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217272-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217272-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217272-001AB11e350fbaab3a…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROFURANTOIN100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
927AH8112LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1648759Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4bac93c7-dd35-4f5a-8067-5c6fcccc729dAvailable 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
71335-2212-1nitrofurantoin macrocrystals40 in 1 BOTTLECAPSULE40100
71335-2212-2nitrofurantoin macrocrystals28 in 1 BOTTLECAPSULE28100
71335-2212-3nitrofurantoin macrocrystals30 in 1 BOTTLECAPSULE30100
71335-2212-4nitrofurantoin macrocrystals20 in 1 BOTTLECAPSULE20100
71335-2212-5nitrofurantoin macrocrystals14 in 1 BOTTLECAPSULE14100
71335-2212-6nitrofurantoin macrocrystals10 in 1 BOTTLECAPSULE10100
71335-2212-7nitrofurantoin macrocrystals12 in 1 BOTTLECAPSULE12100
71335-2212-8nitrofurantoin macrocrystals90 in 1 BOTTLECAPSULE90100
71335-2212-9nitrofurantoin macrocrystals6 in 1 BOTTLECAPSULE6100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2212-6EA - Each71335-22129b00a1c3-b3a1-49f0-8b35-7bcbbe5de72b12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2212NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 9 package rows20230824_4bac93c7-dd35-4f5a-8067-5c6fcccc729d.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 macrocrystalsNITROFURANTOIN MACROCRYSTALSBluePoint Laboratoriescfa20cfd-478f-48c6-9b59-3c425abd766a2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSREMEDYREPACK INC.27f2ed1a-d4c2-4c12-92a6-3d0e9ce7f6a12026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSRedpharm Drug52eea406-abb9-2713-e063-6294a90a00c62026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
Nitrofurantoin MacrocrystalsNITROFURANTOIN MACROCRYSTALSDirect_Rx10d05283-e247-4e60-e063-6294a90ac2922026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSNorthwind Health Company, LLC075fe819-fc4f-2dce-e063-6294a90ad8232025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSVERITYRX, LLC42a1c744-93dc-31cc-e063-6294a90ab9122025-11-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSPD-Rx Pharmaceuticals, Inc.f28d72be-56d7-467f-a3f8-9ffd57d0dffa2025-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSProficient Rx LPef7053f3-3081-49c4-9c78-d40a01177fd92024-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoinNITROFURANTOIN MACROCRYSTALSA-S Medication Solutions4cd9e234-a2b9-4201-b8f8-cf37c0672de72024-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
Nitrofurantoin MacrocrystalsNITROFURANTOIN MACROCRYSTALSAmerican Health Packagingce4afef1-22c1-4a1c-a102-a32fb6a2e0452024-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSNorthStar RxLLC1e3c284a-539d-4923-a5f6-547390baf8112023-10-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSBryant Ranch Prepackaf291b9c-d1b4-42c3-a1e9-bdf3b63fd7e62023-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSBryant Ranch Prepack4bac93c7-dd35-4f5a-8067-5c6fcccc729d2023-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272
ndc (product): 71335-2212
nitrofurantoin macrocrystalsNITROFURANTOIN MACROCRYSTALSLifestar Pharma LLC6ec66cc8-938f-4839-98c7-a51c9f1d50ed2023-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217272
application number: ANDA217272

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648759nitrofurantoin macrocrystals 100 MG Oral CapsulePSN4bac93c7-dd35-4f5a-8067-5c6fcccc729d100
1648759nitrofurantoin, macrocrystals 100 MG Oral CapsuleSCD4bac93c7-dd35-4f5a-8067-5c6fcccc729d100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2212-17133522120140 CAPSULE in 1 BOTTLE (71335-2212-1) 40 capsule2023-08-15NoNoCurrent
71335-2212-27133522120228 CAPSULE in 1 BOTTLE (71335-2212-2) 28 capsule2023-08-15NoNoCurrent
71335-2212-37133522120330 CAPSULE in 1 BOTTLE (71335-2212-3) 30 capsule2023-08-15NoNoCurrent
71335-2212-47133522120420 CAPSULE in 1 BOTTLE (71335-2212-4) 20 capsule2023-08-15NoNoCurrent
71335-2212-57133522120514 CAPSULE in 1 BOTTLE (71335-2212-5) 14 capsule2023-08-15NoNoCurrent
71335-2212-67133522120610 CAPSULE in 1 BOTTLE (71335-2212-6) 10 capsule2023-08-15NoNoCurrent
71335-2212-77133522120712 CAPSULE in 1 BOTTLE (71335-2212-7) 12 capsule2023-08-15NoNoCurrent
71335-2212-87133522120890 CAPSULE in 1 BOTTLE (71335-2212-8) 90 capsule2023-08-15NoNoCurrent
71335-2212-9713352212096 CAPSULE in 1 BOTTLE (71335-2212-9) 6 capsule2023-08-15NoNoCurrent