FDA.reportPublic FDA data

NDC 44087-1116-01 - Gonal-f RFF Redi-ject

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
44087-1116
Requested NDC
44087-1116-01
Package NDCs from labels
44087-1116-1, 44087-1116-01
Manufacturer
EMD Serono, Inc.
Effective date
2025-04-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gonal-f RFF Redi-ject - EMD Serono, Inc.EMD Serono, Inc.2025-04-03HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44087-1116-12022-02-02C16284748780-1d6a99b39-a56a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use GONAL-f ® RFF Redi-ject ® safely and effectively. See full prescribing information for GONAL-f ® RFF Redi-ject ® GONAL-f ® RFF Redi-ject ® (follitropin alfa) injection for subcutaneous use Initial U.S. Approval: 1997
44087-1116-12022-01-28C16284748780-1d6a99b39-a56a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use GONAL-f ® RFF Redi-ject ® safely and effectively. See full prescribing information for GONAL-f ® RFF Redi-ject ® GONAL-f ® RFF Redi-ject ® (follitropin alfa) injection for subcutaneous use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44087-1116-1Gonal-f RFF Redi-ject1 in 1 CARTONINJECTION, SOLUTION113
44087-1116-1Gonal-f RFF Redi-ject0.75 mL in 1 PACKAGEINJECTION, SOLUTION0.7513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44087-1116GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]13Current NDC, Legacy NDC, 2 package rows20250406_b6d11c45-b502-478e-bb28-2ff596ea259c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44087-1116-1ML - Milliliter44087-11164cead4a7-e144-4cd0-b33b-685cf001e7f512014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOLLITROPINACTIVE INGREDIENT076WHW89TWGONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3
FOLLITROPINACTIVE MOIETY076WHW89TWGONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3
METACRESOLINACTIVE INGREDIENTGGO4Y809LOGONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3
METHIONINEINACTIVE INGREDIENTAE28F7PNPLGONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGGONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TGONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNGONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.]3

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 2 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM PHOSPHATESSODIUM PHOSPHATESGLENMARK PHARMACEUTICALS INC., USAc968f70b-a670-4aef-a7e0-89468ad62d9c2026-03-12Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
SODIUM PHOSPHATESSODIUM PHOSPHATESCaplin Steriles Limited46de992b-5fc8-4dad-8d95-77938decb67e2026-03-10Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
E.O.L.STILLINGIA SYLVATICA, ZINCUM GLUCONICUM, THIAMINUM HYDROCHLORICUM, FRAGARIA VESCA, NICOTINAMIDUM, RHEUM (PALMATUM), SEROTONIN (HYDROCHLORIDE), 5-HYDROXYTRYPTOPHAN, BETAINUM MURIATICUM, BIOTIN, CHOLINUM, CYSTEINUM, DL-METHIONINE, L-ALANINE, L-CYSTINE, L-GLUTAMIC ACID, L-GLUTAMINE, L-LYSINE, L-METHIONINE, L-SERINE, PARA-AMINOBENZOIC ACID, POTASSIUM GLUCONATE, THYMUS (SUIS), THYROIDINUM (SUIS), UBIDECARENONUM, VITAMIN D3, DOPAMINE HYDROCHLORIDE, LITHIUM BROMATUM, SQUALENE, VACCINIUM MACROCARPON, OXYTOCIN,InLight Creation, LLC.b317d812-d6ed-4a2f-93f7-08b12261cc992026-01-09WarningsExact identifier
unii: AE28F7PNPL
SAMe Liquescence 3036SAME LIQUESCENCEProfessional Complementary Health Formulas2a706f5a-62f5-4479-9686-5d0285fe529c2026-01-08WarningsExact identifier
unii: AE28F7PNPL
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: C151H8M554
Substance Abuse Drops 2063SUBSTANCE ABUSE DROPSProfessional Complementary Health Formulas61f8263d-6f72-442f-a09e-57daf7226cc72026-01-08WarningsExact identifier
unii: C151H8M554
Anti-Smoking I Drops 2007ANTI-SMOKING I DROPSProfessional Complementary Health Formulas1c6b5b98-971d-442a-b9eb-37f65409a5212026-01-08WarningsExact identifier
unii: C151H8M554
L-Methionine 7417L-METHIONINEProfessional Complementary Health Formulas733cd224-813e-4e69-8aff-c8ec4ced325a2026-01-08WarningsExact identifier
unii: AE28F7PNPL
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: C151H8M554
L-Methionine High 7418L-METHIONINE HIGHProfessional Complementary Health Formulasb87f55ca-af0e-4017-b9e3-8fb8b70b278d2026-01-08WarningsExact identifier
unii: AE28F7PNPL
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
unii: 593YOG76RN
Uretron D/SMETHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticalsea74f1aa-2b4d-4ccf-e053-2995a90abab52025-12-18Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Aminosyn IIISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINEICU Medical Inc.5b426208-f090-4650-86c3-89040ba45c2d2025-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: AE28F7PNPL
Ionosol MB and DextroseDEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEICU Medical Inc.1b457b1d-0e80-4578-ba6f-dedf513fc9622025-10-30Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Me NaPhos MB Hyo 1URINARY ANTISEPTIC ANTISPASMODICMethod Pharmaceuticals2ae628e7-3b33-6a9a-e054-00144ff8d46c2025-10-21Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: C151H8M554
Aminosyn-PFISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINEICU Medical Inc.2d212e10-7e08-4aeb-b63f-dcc9278977692025-10-17Warnings, Adverse reactionsExact identifier
unii: AE28F7PNPL
Aminosyn-PFISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINEICU Medical Inc.46e74ce4-cd7e-437f-bf54-ca9b98eb26632025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: AE28F7PNPL
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: AE28F7PNPL

Reported adverse events (FAERS/openFDA)#

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