76297-002-31

Product NDC
76297-002
Requested package NDC
76297-002-31
11-digit product format
762970002
Labeler code
76297
Product ID
76297-002_f366b0fc-c1b4-47cb-a976-53f8ba81a2b6
Type
DRUG FOR FURTHER PROCESSING
Nonproprietary name
water
Dosage form
SOLUTION
Marketing category
DRUG FOR FURTHER PROCESSING
Marketing start
2016-02-04
Substance
WATER
Active strength
1 mL/mL
Listing certified through
2027-12-31
Current FDA listing
Yes

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
unfinished packagepackage76297-00276297-002-31UNFINISHEDActive or certified unfinished drug listing2026-08-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-305b2001dcd8f5…54b53d4dc9e4…

Additional Listing Data#

Finished product
No
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WATER1 mL/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac74f96-3910-44b9-8551-036880fbb1fbProduct name120260108
0a18eae4-4259-42db-86b6-915f66e83b06Product name120250729
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
2c999b01-2a13-4eff-8eb4-00b87316ef79Product name120231116
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76297-002-02Profilnine5 mL in 1 VIAL, GLASSSOLUTION5 mL1 mL in 1mL33
76297-002-12Profilnine10 mL in 1 VIAL, GLASSSOLUTION10 mL1 mL in 1mL33
76297-002-12Profilnine10 mL in 1 VIAL, GLASSSOLUTION10 mL1 mL in 1mL33
76297-002-12THROMBATE III10 mL in 1 VIAL, GLASSSOLUTION10 mL1 mL in 1mL31
76297-002-02Alphanate5 mL in 1 VIAL, GLASSSOLUTION5 mL1 mL in 1mL26
76297-002-02Alphanate5 mL in 1 VIAL, GLASSSOLUTION5 mL1 mL in 1mL26
76297-002-12Alphanate10 mL in 1 VIAL, GLASSSOLUTION10 mL1 mL in 1mL26
76297-002-12Alphanate10 mL in 1 VIAL, GLASSSOLUTION10 mL1 mL in 1mL26
76297-002-12Alphanate10 mL in 1 VIAL, GLASSSOLUTION10 mL1 mL in 1mL26
76297-002-12AlphaNine SD10 mL in 1 VIAL, GLASSSOLUTION10 mL1 mL in 1mL25
76297-002-12AlphaNine SD10 mL in 1 VIAL, GLASSSOLUTION10 mL1 mL in 1mL25
76297-002-12AlphaNine SD10 mL in 1 VIAL, GLASSSOLUTION10 mL1 mL in 1mL25
76297-002-22PROLASTIN-C20 mL in 1 VIAL, SINGLE-DOSESOLUTION20 mL1 mL in 1mL25
76297-002-02Koate5 mL in 1 VIAL, GLASSSOLUTION5 mL1 mL in 1mL23
76297-002-02Koate5 mL in 1 VIAL, GLASSSOLUTION5 mL1 mL in 1mL23
76297-002-12Koate10 mL in 1 VIAL, GLASSSOLUTION10 mL1 mL in 1mL23
76297-002-02Koate5 mL in 1 VIAL, GLASSSOLUTION5 mL1 mL in 1mL10
76297-002-02Koate5 mL in 1 VIAL, GLASSSOLUTION5 mL1 mL in 1mL10
76297-002-12Koate10 mL in 1 VIAL, GLASSSOLUTION10 mL1 mL in 1mL10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
factor ix complexACTIVE INGREDIENTFW411QXD5MPROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]15
factor ix complexACTIVE MOIETYFW411QXD5MPROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]15
sodium chlorideINACTIVE INGREDIENT451W47IQ8XPROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]15
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRPROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]15
sodium phosphateINACTIVE INGREDIENTSE337SVY37PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]15
Alpha-1-proteinase Inhibitor HumanACTIVE INGREDIENTF43I396OISPROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13
Alpha-1-proteinase Inhibitor HumanACTIVE MOIETYF43I396OISPROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XPROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13
Sodium PhosphateINACTIVE INGREDIENTSE337SVY37PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]13
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEXACTIVE INGREDIENT5T6B772R4QALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]12
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEXACTIVE MOIETY5T6B772R4QALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]12
albumin (human)INACTIVE INGREDIENTZIF514RVZRALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]12
arginineINACTIVE INGREDIENT94ZLA3W45FALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]12
histidineINACTIVE INGREDIENT4QD397987EALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]12
Antihemophilic Factor HumanACTIVE INGREDIENT839MOZ74GKKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Antithrombin Iii HumanACTIVE INGREDIENTT0LTO7L82XTHROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]11
Antihemophilic Factor HumanACTIVE MOIETY839MOZ74GKKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Antithrombin Iii HumanACTIVE MOIETYT0LTO7L82XTHROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]11
Albumin (human)INACTIVE INGREDIENTZIF514RVZRKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
AluminumINACTIVE INGREDIENTCPD4NFA903KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Calcium ChlorideINACTIVE INGREDIENTM4I0D6VV5MKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
GlycineINACTIVE INGREDIENTTE7660XO1CKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
HistidineINACTIVE INGREDIENT4QD397987EKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XKOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
Tri-n-butyl PhosphateINACTIVE INGREDIENT95UAS8YAF5KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]11
COAGULATION FACTOR IX HUMANACTIVE INGREDIENT6U90Y1795TALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10
Coagulation Factor IX HumanACTIVE MOIETY6U90Y1795TALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10
dextroseINACTIVE INGREDIENTIY9XDZ35W2ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10
heparinINACTIVE INGREDIENTT2410KM04AALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10
sodium chlorideINACTIVE INGREDIENT451W47IQ8XALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76297-002PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]29Unmatched20230830_79821042-86a5-4a64-b621-76de0a0bbab2.zip
76297-002THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT [GRIFOLS USA, LLC]29Unmatched20231222_b2a9f856-3ef7-8da4-920c-f738e4f1f7d7.zip
76297-002ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]25Unmatched20231009_5a7aea94-654c-4113-9014-c3137de0a931.zip
76297-002PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT [GRIFOLS USA, LLC]25Unmatched20220308_91edab72-c889-470e-8315-1798b5548dca.zip
76297-002ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]24Unmatched20240123_3e99052d-4442-4283-8915-c9a796c77008.zip
76297-002KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.]23Unmatched20231228_2f77d685-e382-b2e7-2414-0d3a3448688a.zip
76297-002KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.]10Unmatched20231228_865df1e2-b4d1-dbf5-2899-a9c02df4d122.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670387factor IX complex 1 UNT InjectionPSN79821042-86a5-4a64-b621-76de0a0bbab233
1670392Profilnine SD 1 UNT InjectionPSN79821042-86a5-4a64-b621-76de0a0bbab233
1670392factor IX complex 1 UNT Injection [Profilnine]SBD79821042-86a5-4a64-b621-76de0a0bbab233
1670387factor IX complex 1 UNT InjectionSCD79821042-86a5-4a64-b621-76de0a0bbab233
1670392Profilnine 1 UNT InjectionSY79821042-86a5-4a64-b621-76de0a0bbab233
1659988antithrombin III, human 1 UNT InjectionPSNb2a9f856-3ef7-8da4-920c-f738e4f1f7d731
1659991Thrombate III 1 UNT InjectionPSNb2a9f856-3ef7-8da4-920c-f738e4f1f7d731
1659991antithrombin III, human 1 UNT Injection [Thrombate III]SBDb2a9f856-3ef7-8da4-920c-f738e4f1f7d731
1659988antithrombin III, human 1 UNT InjectionSCDb2a9f856-3ef7-8da4-920c-f738e4f1f7d731
1659991Thrombate III 1 UNT InjectionSYb2a9f856-3ef7-8da4-920c-f738e4f1f7d731
1661345Alphanate (expressed as von Willebrand factor) 1 UNT InjectionPSN5a7aea94-654c-4113-9014-c3137de0a93126
1661332antihemophilic factor / von Willebrand factor complex, human 1 UNT InjectionPSN5a7aea94-654c-4113-9014-c3137de0a93126
1661345factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT Injection [Alphanate]SBD5a7aea94-654c-4113-9014-c3137de0a93126
1661332factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT InjectionSCD5a7aea94-654c-4113-9014-c3137de0a93126
1661345Alphanate (expressed as von Willebrand factor) 1 UNT InjectionSY5a7aea94-654c-4113-9014-c3137de0a93126
1661332factor VIII / von Willebrand Factor complex, human 1 UNT InjectionSY5a7aea94-654c-4113-9014-c3137de0a93126
1661208alpha 1-proteinase inhibitor, human 1 MG InjectionPSN91edab72-c889-470e-8315-1798b5548dca25
1666309AlphaNine SD 1 UNT InjectionPSN3e99052d-4442-4283-8915-c9a796c7700825
1666303factor IX, human 1 UNT InjectionPSN3e99052d-4442-4283-8915-c9a796c7700825
1661220Prolastin-C 1 MG InjectionPSN91edab72-c889-470e-8315-1798b5548dca25
1661220alpha 1-proteinase inhibitor, human 1 MG Injection [Prolastin]SBD91edab72-c889-470e-8315-1798b5548dca25
1666309coagulation factor IX, human 1 UNT Injection [Alphanine SD]SBD3e99052d-4442-4283-8915-c9a796c7700825
1661208alpha 1-proteinase inhibitor, human 1 MG InjectionSCD91edab72-c889-470e-8315-1798b5548dca25
1666303coagulation factor IX, human 1 UNT InjectionSCD3e99052d-4442-4283-8915-c9a796c7700825
1666309Alphanine SD 1 UNT InjectionSY3e99052d-4442-4283-8915-c9a796c7700825
1661220Prolastin 1 MG InjectionSY91edab72-c889-470e-8315-1798b5548dca25
1718962antihemophilic factor, human 1 UNT InjectionPSN2f77d685-e382-b2e7-2414-0d3a3448688a23
1718970Koate-DVI 1 UNT InjectionPSN2f77d685-e382-b2e7-2414-0d3a3448688a23
1718970antihemophilic factor, human 1 UNT Injection [Koate]SBD2f77d685-e382-b2e7-2414-0d3a3448688a23
1718962antihemophilic factor, human 1 UNT InjectionSCD2f77d685-e382-b2e7-2414-0d3a3448688a23
1718962factor VIII, human 1 UNT InjectionSY2f77d685-e382-b2e7-2414-0d3a3448688a23
1718970Koate 1 UNT InjectionSY2f77d685-e382-b2e7-2414-0d3a3448688a23
1718962antihemophilic factor, human 1 UNT InjectionPSN865df1e2-b4d1-dbf5-2899-a9c02df4d12210
1718970Koate-DVI 1 UNT InjectionPSN865df1e2-b4d1-dbf5-2899-a9c02df4d12210
1718970antihemophilic factor, human 1 UNT Injection [Koate]SBD865df1e2-b4d1-dbf5-2899-a9c02df4d12210
1718962antihemophilic factor, human 1 UNT InjectionSCD865df1e2-b4d1-dbf5-2899-a9c02df4d12210
1718962factor VIII, human 1 UNT InjectionSY865df1e2-b4d1-dbf5-2899-a9c02df4d12210
1718970Koate 1 UNT InjectionSY865df1e2-b4d1-dbf5-2899-a9c02df4d12210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
76297-002-317629700023142 VIAL in 1 CASE (76297-002-31) / 30 mL in 1 VIAL42 vial04-FEB-16Current