76297-002-01
- Product NDC
- 76297-002
- Requested package NDC
- 76297-002-01
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| unfinished package | package | 76297-002 | 76297-002-01 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-12 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | 50b4072663b7… | eae3003ed65e… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | 906f6e251498… | bf70b80e44f0… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | 8fc7167e32ce… | e96bbc724034… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | 4184dd79f89f… | 545327b3e20f… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | 4bd3596a7b87… | 5c64c6f6865f… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | 263afe128892… | 91768de4ddbe… |
| 2019-06-01 22:24 UTC · source 2019-05-30 | 5b2001dcd8f5… | 54b53d4dc9e4… |
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| WATER | 1 mL/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76297-002-02 | Profilnine | 5 mL in 1 VIAL, GLASS | SOLUTION | 5 mL | 1 mL in 1mL | 33 |
| 76297-002-12 | Profilnine | 10 mL in 1 VIAL, GLASS | SOLUTION | 10 mL | 1 mL in 1mL | 33 |
| 76297-002-12 | Profilnine | 10 mL in 1 VIAL, GLASS | SOLUTION | 10 mL | 1 mL in 1mL | 33 |
| 76297-002-12 | THROMBATE III | 10 mL in 1 VIAL, GLASS | SOLUTION | 10 mL | 1 mL in 1mL | 31 |
| 76297-002-02 | Alphanate | 5 mL in 1 VIAL, GLASS | SOLUTION | 5 mL | 1 mL in 1mL | 26 |
| 76297-002-02 | Alphanate | 5 mL in 1 VIAL, GLASS | SOLUTION | 5 mL | 1 mL in 1mL | 26 |
| 76297-002-12 | Alphanate | 10 mL in 1 VIAL, GLASS | SOLUTION | 10 mL | 1 mL in 1mL | 26 |
| 76297-002-12 | Alphanate | 10 mL in 1 VIAL, GLASS | SOLUTION | 10 mL | 1 mL in 1mL | 26 |
| 76297-002-12 | Alphanate | 10 mL in 1 VIAL, GLASS | SOLUTION | 10 mL | 1 mL in 1mL | 26 |
| 76297-002-12 | AlphaNine SD | 10 mL in 1 VIAL, GLASS | SOLUTION | 10 mL | 1 mL in 1mL | 25 |
| 76297-002-12 | AlphaNine SD | 10 mL in 1 VIAL, GLASS | SOLUTION | 10 mL | 1 mL in 1mL | 25 |
| 76297-002-12 | AlphaNine SD | 10 mL in 1 VIAL, GLASS | SOLUTION | 10 mL | 1 mL in 1mL | 25 |
| 76297-002-22 | PROLASTIN-C | 20 mL in 1 VIAL, SINGLE-DOSE | SOLUTION | 20 mL | 1 mL in 1mL | 25 |
| 76297-002-02 | Koate | 5 mL in 1 VIAL, GLASS | SOLUTION | 5 mL | 1 mL in 1mL | 23 |
| 76297-002-02 | Koate | 5 mL in 1 VIAL, GLASS | SOLUTION | 5 mL | 1 mL in 1mL | 23 |
| 76297-002-12 | Koate | 10 mL in 1 VIAL, GLASS | SOLUTION | 10 mL | 1 mL in 1mL | 23 |
| 76297-002-02 | Koate | 5 mL in 1 VIAL, GLASS | SOLUTION | 5 mL | 1 mL in 1mL | 10 |
| 76297-002-02 | Koate | 5 mL in 1 VIAL, GLASS | SOLUTION | 5 mL | 1 mL in 1mL | 10 |
| 76297-002-12 | Koate | 10 mL in 1 VIAL, GLASS | SOLUTION | 10 mL | 1 mL in 1mL | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76297-002 | PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] | 29 | Unmatched | 20230830_79821042-86a5-4a64-b621-76de0a0bbab2.zip |
| 76297-002 | THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT [GRIFOLS USA, LLC] | 29 | Unmatched | 20231222_b2a9f856-3ef7-8da4-920c-f738e4f1f7d7.zip |
| 76297-002 | ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] | 25 | Unmatched | 20231009_5a7aea94-654c-4113-9014-c3137de0a931.zip |
| 76297-002 | PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT [GRIFOLS USA, LLC] | 25 | Unmatched | 20220308_91edab72-c889-470e-8315-1798b5548dca.zip |
| 76297-002 | ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] | 24 | Unmatched | 20240123_3e99052d-4442-4283-8915-c9a796c77008.zip |
| 76297-002 | KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.] | 23 | Unmatched | 20231228_2f77d685-e382-b2e7-2414-0d3a3448688a.zip |
| 76297-002 | KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.] | 10 | Unmatched | 20231228_865df1e2-b4d1-dbf5-2899-a9c02df4d122.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1670387 | factor IX complex 1 UNT Injection | PSN | 79821042-86a5-4a64-b621-76de0a0bbab2 | 33 |
| 1670392 | Profilnine SD 1 UNT Injection | PSN | 79821042-86a5-4a64-b621-76de0a0bbab2 | 33 |
| 1670392 | factor IX complex 1 UNT Injection [Profilnine] | SBD | 79821042-86a5-4a64-b621-76de0a0bbab2 | 33 |
| 1670387 | factor IX complex 1 UNT Injection | SCD | 79821042-86a5-4a64-b621-76de0a0bbab2 | 33 |
| 1670392 | Profilnine 1 UNT Injection | SY | 79821042-86a5-4a64-b621-76de0a0bbab2 | 33 |
| 1659988 | antithrombin III, human 1 UNT Injection | PSN | b2a9f856-3ef7-8da4-920c-f738e4f1f7d7 | 31 |
| 1659991 | Thrombate III 1 UNT Injection | PSN | b2a9f856-3ef7-8da4-920c-f738e4f1f7d7 | 31 |
| 1659991 | antithrombin III, human 1 UNT Injection [Thrombate III] | SBD | b2a9f856-3ef7-8da4-920c-f738e4f1f7d7 | 31 |
| 1659988 | antithrombin III, human 1 UNT Injection | SCD | b2a9f856-3ef7-8da4-920c-f738e4f1f7d7 | 31 |
| 1659991 | Thrombate III 1 UNT Injection | SY | b2a9f856-3ef7-8da4-920c-f738e4f1f7d7 | 31 |
| 1661345 | Alphanate (expressed as von Willebrand factor) 1 UNT Injection | PSN | 5a7aea94-654c-4113-9014-c3137de0a931 | 26 |
| 1661332 | antihemophilic factor / von Willebrand factor complex, human 1 UNT Injection | PSN | 5a7aea94-654c-4113-9014-c3137de0a931 | 26 |
| 1661345 | factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT Injection [Alphanate] | SBD | 5a7aea94-654c-4113-9014-c3137de0a931 | 26 |
| 1661332 | factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT Injection | SCD | 5a7aea94-654c-4113-9014-c3137de0a931 | 26 |
| 1661345 | Alphanate (expressed as von Willebrand factor) 1 UNT Injection | SY | 5a7aea94-654c-4113-9014-c3137de0a931 | 26 |
| 1661332 | factor VIII / von Willebrand Factor complex, human 1 UNT Injection | SY | 5a7aea94-654c-4113-9014-c3137de0a931 | 26 |
| 1661208 | alpha 1-proteinase inhibitor, human 1 MG Injection | PSN | 91edab72-c889-470e-8315-1798b5548dca | 25 |
| 1666309 | AlphaNine SD 1 UNT Injection | PSN | 3e99052d-4442-4283-8915-c9a796c77008 | 25 |
| 1666303 | factor IX, human 1 UNT Injection | PSN | 3e99052d-4442-4283-8915-c9a796c77008 | 25 |
| 1661220 | Prolastin-C 1 MG Injection | PSN | 91edab72-c889-470e-8315-1798b5548dca | 25 |
| 1661220 | alpha 1-proteinase inhibitor, human 1 MG Injection [Prolastin] | SBD | 91edab72-c889-470e-8315-1798b5548dca | 25 |
| 1666309 | coagulation factor IX, human 1 UNT Injection [Alphanine SD] | SBD | 3e99052d-4442-4283-8915-c9a796c77008 | 25 |
| 1661208 | alpha 1-proteinase inhibitor, human 1 MG Injection | SCD | 91edab72-c889-470e-8315-1798b5548dca | 25 |
| 1666303 | coagulation factor IX, human 1 UNT Injection | SCD | 3e99052d-4442-4283-8915-c9a796c77008 | 25 |
| 1666309 | Alphanine SD 1 UNT Injection | SY | 3e99052d-4442-4283-8915-c9a796c77008 | 25 |
| 1661220 | Prolastin 1 MG Injection | SY | 91edab72-c889-470e-8315-1798b5548dca | 25 |
| 1718962 | antihemophilic factor, human 1 UNT Injection | PSN | 2f77d685-e382-b2e7-2414-0d3a3448688a | 23 |
| 1718970 | Koate-DVI 1 UNT Injection | PSN | 2f77d685-e382-b2e7-2414-0d3a3448688a | 23 |
| 1718970 | antihemophilic factor, human 1 UNT Injection [Koate] | SBD | 2f77d685-e382-b2e7-2414-0d3a3448688a | 23 |
| 1718962 | antihemophilic factor, human 1 UNT Injection | SCD | 2f77d685-e382-b2e7-2414-0d3a3448688a | 23 |
| 1718962 | factor VIII, human 1 UNT Injection | SY | 2f77d685-e382-b2e7-2414-0d3a3448688a | 23 |
| 1718970 | Koate 1 UNT Injection | SY | 2f77d685-e382-b2e7-2414-0d3a3448688a | 23 |
| 1718962 | antihemophilic factor, human 1 UNT Injection | PSN | 865df1e2-b4d1-dbf5-2899-a9c02df4d122 | 10 |
| 1718970 | Koate-DVI 1 UNT Injection | PSN | 865df1e2-b4d1-dbf5-2899-a9c02df4d122 | 10 |
| 1718970 | antihemophilic factor, human 1 UNT Injection [Koate] | SBD | 865df1e2-b4d1-dbf5-2899-a9c02df4d122 | 10 |
| 1718962 | antihemophilic factor, human 1 UNT Injection | SCD | 865df1e2-b4d1-dbf5-2899-a9c02df4d122 | 10 |
| 1718962 | factor VIII, human 1 UNT Injection | SY | 865df1e2-b4d1-dbf5-2899-a9c02df4d122 | 10 |
| 1718970 | Koate 1 UNT Injection | SY | 865df1e2-b4d1-dbf5-2899-a9c02df4d122 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Status |
|---|---|---|---|---|---|
| 76297-002-01 | 76297000201 | 77 VIAL in 1 CASE (76297-002-01) / 5 mL in 1 VIAL | 77 vial | 04-FEB-16 | Current |