Macrobid

Product NDC
52427-285
11-digit product format
524270285
Labeler code
52427
Product ID
52427-285_83236f78-20ec-6005-4b09-cc2470a1b36a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin Monohydrate/Macrocrystalline
Dosage form
CAPSULE
Route
ORAL
Labeler
Almatica Pharma LLC
Application
NDA020064
Marketing category
NDA
Marketing start
2011-05-31
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
N020064-001MACROBIDNITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020064-001AB

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 06:07:402026-07N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-243f01610625f2…
2019-09-15 20:21 UTC2019-09N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020064-001MACROBID75MG;25MGCAPSULE / ORALABRLD, RS1991-12-24e64feba35796…

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 06:07:402026-07N020064-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020064-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020064-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020064-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020064-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020064-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020064-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020064-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020064-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020064-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020064-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020064-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020064-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020064-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020064-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020064-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020064-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020064-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020064-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020064-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020064-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020064-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020064-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020064-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020064-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020064-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020064-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020064-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020064-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020064-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020064-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020064-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020064-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020064-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020064-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020064-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020064-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020064-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020064-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020064-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Macrobid
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
539712Internal RxNorm lookup
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
8f270a9f-12a1-44d4-bc7e-873613555801Available 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
52427-285-01Macrobid100 in 1 BOTTLECAPSULE10026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52427-285-01EA - Each52427-285eb6c3871-6aeb-4aee-9380-3b3a265ebf7d12013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROFURANTOINACTIVE INGREDIENT927AH8112LMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
NITROFURANTOIN MONOHYDRATEACTIVE INGREDIENTE1QI2CQQ1IMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
NITROFURANTOINACTIVE MOIETY927AH8112LMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
CARBOMER 934INACTIVE INGREDIENTZ135WT9208MACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
GELATININACTIVE INGREDIENT2G86QN327LMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
POVIDONEINACTIVE INGREDIENTFZ989GH94EMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
TALCINACTIVE INGREDIENT7SEV7J4R1UMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA INC.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52427-285MACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [ALMATICA PHARMA LLC]24Current NDC, Legacy NDC, 1 package rows20241010_8f270a9f-12a1-44d4-bc7e-873613555801.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nitrofurantoin Monohydrate/ MacrocrystallineNITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINEREMEDYREPACK INC.a4afd48b-003f-4ffa-9ca0-9432b8b0e22b2026-06-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 020064
application number: NDA020064
MacrobidNITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINEREMEDYREPACK INC.28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e2026-02-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 020064
application number: NDA020064
Nitrofurantoin Monohydrate/ MacrocrystallineNITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINEAlvogen Inc.1a86deef-0887-43b1-bb96-dbc222b159312025-10-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 020064
application number: NDA020064
MacrobidNITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINEAlmatica Pharma LLC8f270a9f-12a1-44d4-bc7e-8736135558012025-10-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 020064
application number: NDA020064
ndc (product): 52427-285
NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINENITROFURANTOIN MONOHYDRATEDirect_Rx8d2e456a-ffb2-3f1e-e053-2995a90a22df2025-07-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 020064
application number: NDA020064
Nitrofurantoin MonoNITROFURANTOIN MONOHYDRATEPharmPak, Inc.d9840719-271f-42a9-a5c9-3e039ec8fbac2022-10-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 020064
application number: NDA020064
Nitrofurantoin Monohydrate/ MacrocrystallineNITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINEProficient Rx LP22061f76-2c05-4501-b8dd-a5c372abe7c22022-10-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020064
application number: NDA020064

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
539712Macrobid 100 MG Oral CapsulePSN8f270a9f-12a1-44d4-bc7e-87361355580126
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN8f270a9f-12a1-44d4-bc7e-87361355580126
539712nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule [Macrobid]SBD8f270a9f-12a1-44d4-bc7e-87361355580126
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD8f270a9f-12a1-44d4-bc7e-87361355580126
539712Macrobid 100 MG (as nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG) Oral CapsuleSY8f270a9f-12a1-44d4-bc7e-87361355580126
539712Macrobid 100 MG Oral CapsulePSN28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e9
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e9
539712nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule [Macrobid]SBD28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e9
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e9
539712Macrobid 100 MG (as nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG) Oral CapsuleSY28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e9
539712Macrobid 100 MG Oral CapsulePSN718ef4cc-ea45-43c5-9950-be7698f5f2df1
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN718ef4cc-ea45-43c5-9950-be7698f5f2df1
539712nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule [Macrobid]SBD718ef4cc-ea45-43c5-9950-be7698f5f2df1
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD718ef4cc-ea45-43c5-9950-be7698f5f2df1
539712Macrobid 100 MG (as nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG) Oral CapsuleSY718ef4cc-ea45-43c5-9950-be7698f5f2df1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52427-285-0152427028501100 CAPSULE in 1 BOTTLE (52427-285-01) 100 capsule2011-05-310000-00-00NoNoCurrent