FDA.reportPublic FDA data

Nitrofurantoin

Product NDC
13811-719
11-digit product format
138110719
Labeler code
13811
Product ID
13811-719_fb696b06-d8b4-81df-e053-6394a90af1e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Trigen Laboratories, LLC
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

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 Identifiers#

Field, Values table
FieldValues
Unii927AH8112L, E1QI2CQQ1I
Rxcui1648755

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
13811-719-10Nitrofurantoin100 in 1 BOTTLECAPSULE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-719-10EA - Each13811-7194c26ce40-f62a-4754-9460-56f3388ca9ed12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13811-719NITROFURANTOIN CAPSULE [TRIGEN LABORATORIES, LLC]6Current NDC, Legacy NDC, 1 package rows20230512_39ffb8c6-4dd8-4436-b857-7306c15f662a.zip

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
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN75dab97e-59b4-447c-a8c9-b4d5a970098f101
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN56e07ad3-7224-4aaf-9a68-0d48d4abfec8101
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD56e07ad3-7224-4aaf-9a68-0d48d4abfec8101
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD75dab97e-59b4-447c-a8c9-b4d5a970098f101
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN1c5db054-58af-4932-8fad-c3883b13f987100
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNb807bd48-71ab-4578-b1d7-4d3260bf6c75100
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD1c5db054-58af-4932-8fad-c3883b13f987100
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDb807bd48-71ab-4578-b1d7-4d3260bf6c75100
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN37606c6f-0d85-4314-94ae-f7732c7bc8d59
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN6c82b95d-2c32-4e54-a8a9-a4bb4df70cb59
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD37606c6f-0d85-4314-94ae-f7732c7bc8d59
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD6c82b95d-2c32-4e54-a8a9-a4bb4df70cb59
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNd88348a0-6ab4-4490-9325-1f14a541b0a58
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDd88348a0-6ab4-4490-9325-1f14a541b0a58
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN39ffb8c6-4dd8-4436-b857-7306c15f662a6
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD39ffb8c6-4dd8-4436-b857-7306c15f662a6
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN729f6bbb-ab64-4b65-979a-4ad7605c59475
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNee13cf2a-cde0-8ab8-e053-2a95a90a9dda5
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDee13cf2a-cde0-8ab8-e053-2a95a90a9dda5
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD729f6bbb-ab64-4b65-979a-4ad7605c59475
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNf40af3e1-e54c-3a35-e053-2a95a90a6cb23
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDf40af3e1-e54c-3a35-e053-2a95a90a6cb23
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNf4c2c01d-bef7-3e5d-e053-2995a90ae0d82
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNf7f9db2f-4111-efc5-e053-6294a90a00922
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDf4c2c01d-bef7-3e5d-e053-2995a90ae0d82
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDf7f9db2f-4111-efc5-e053-6294a90a00922
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN34d3c103-27b8-454b-9f38-c33157c3b6fc1
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSNf40f84ab-81b1-0f56-e053-2995a90a1d3d1
1648755nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral CapsulePSN09944470-807d-ad37-e063-6394a90a7bfe1
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD34d3c103-27b8-454b-9f38-c33157c3b6fc1
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCDf40f84ab-81b1-0f56-e053-2995a90a1d3d1
1648755nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral CapsuleSCD09944470-807d-ad37-e063-6394a90a7bfe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13811-719-1013811071910100 CAPSULE in 1 BOTTLE (13811-719-10) 100 capsule2018-01-010000-00-00NoNoCurrent