Nitrofurantoin (monohydrate/macrocrystals)

Product NDC
71205-546
Requested package NDC
71205-546-20
11-digit product format
712050546
Labeler code
71205
Product ID
71205-546_ffdcd017-8fc8-4cd2-9319-06e3d2e7f3e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin (monohydrate/macrocrystals)
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077066
Marketing category
ANDA
Marketing start
2014-11-01
Marketing end
0000-00-00
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25 mg/1; mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71205-54671205-546-20DDiscontinued by firm2026-08-03

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
A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE75MG;25MGCAPSULE / ORALAB2005-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077066-001AB

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 UTC2026-02A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-053f01610625f2…
2019-09-15 20:21 UTC2019-09A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077066-001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)75MG;25MGCAPSULE / ORALAB2005-04-05cb3db0bc1861…

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 UTC2026-02A077066-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077066-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077066-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077066-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077066-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077066-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077066-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077066-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077066-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077066-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077066-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077066-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077066-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077066-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077066-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077066-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077066-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077066-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077066-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077066-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077066-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077066-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077066-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077066-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077066-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077066-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077066-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077066-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077066-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077066-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077066-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077066-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077066-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077066-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077066-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077066-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077066-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077066-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077066-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077066-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-546-10EA - Each71205-546d71fdac5-709e-4d0d-835e-38545d0b325012021-06-02
71205-546-14EA - Each71205-546c44eb540-248d-4a0a-ad6b-254f02e2fe3612021-06-02
71205-546-20EA - Each71205-546e50695cc-4865-4ba3-80c3-c7aa7fc60d6a12021-06-02
71205-546-30EA - Each71205-5463d66ef03-d7ac-4818-8ca1-6395b2fa299612021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-546NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [PROFICIENT RX LP]2Legacy NDC20220409_98c50178-3150-42a5-84f0-65b373f4978f.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
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)REMEDYREPACK INC.ae892973-9ef4-4cf0-baf3-fbe158697bac2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077066
application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)St. Mary's Medical Park Pharmacy87210c87-b7db-0f65-e053-2a91aa0a43932026-06-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077066
application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Northwind Health Company, LLC0631d961-ef23-8f2a-e063-6294a90aa0a82026-01-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077066
application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)PD-Rx Pharmaceuticals, Inc.7767697f-4dd0-477d-b5cc-e1ed5689f0972026-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077066
application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)PD-Rx Pharmaceuticals, Inc.643cdcff-8599-4326-b3ca-d9fd270e0fc22026-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077066
application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Northwind Health Company, LLC04b4189e-9b21-78ed-e063-6394a90ab8e02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077066
application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)QPharma, Inc.fbc05ccb-782b-55f6-e053-6394a90a7fd62025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077066
application number: ANDA077066
NitrofurantoinNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)A-S Medication Solutionsb644426c-c8ba-4fe0-80c7-d9b2dde373952025-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077066
application number: ANDA077066
NITROFURANTOINNITROFURANTOINDirectrxd4385368-46d6-8397-e053-2a95a90a8d682025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077066
application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NuCare Pharmaceuticals,Inc.68a651f9-1aef-792e-e053-2991aa0a3cbb2024-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077066
application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NuCare Pharmaceuticals,Inc.6bccbaab-151b-4a04-e053-2991aa0ae1052024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077066
application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Sandoz Inc7ba9a729-a73a-4a13-a336-0284cc8a67e12024-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077066
application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Bryant Ranch Prepack05f4b126-0fb9-5ee9-c89c-f229e60f84e32023-11-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077066
application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Asclemed USA, Inc.1ab658f0-021a-46a1-bff3-d3334c23442d2022-09-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077066
application number: ANDA077066
Nitrofurantoin (monohydrate/macrocrystals)NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Proficient Rx LPd802d734-dc8f-4f3c-bce6-aaccc4614c892022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077066
application number: ANDA077066

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-546-207120505462020 CAPSULE in 1 BOTTLE (71205-546-20) 20 capsule2021-03-230000-00-00NoNoCurrent