76297-002

Product NDC: 76297-002
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	76297-002		UNFINISHED	Active or certified unfinished drug listing		2026-08-12
unfinished package	package	76297-002	76297-002-01	UNFINISHED	Active or certified unfinished drug listing		2026-08-12
unfinished package	package	76297-002	76297-002-11	UNFINISHED	Active or certified unfinished drug listing		2026-08-12
unfinished package	package	76297-002	76297-002-21	UNFINISHED	Active or certified unfinished drug listing		2026-08-12
unfinished package	package	76297-002	76297-002-31	UNFINISHED	Active or certified unfinished drug listing		2026-08-12
unfinished package	package	76297-002	76297-002-41	UNFINISHED	Active or certified unfinished drug listing		2026-08-12
unfinished package	package	76297-002	76297-002-51	UNFINISHED	Active or certified unfinished drug listing		2026-08-12
unfinished package	package	76297-002	76297-002-71	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.

Historic NDC status page 1 of 3 · 170 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	76297-002-71	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	76297-002-01	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	76297-002-11	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	76297-002-51	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	76297-002-41	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	76297-002-21	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	76297-002-31	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	76297-002-71	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	76297-002-01	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	76297-002-11	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	76297-002-51	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	76297-002-41	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	76297-002-21	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	76297-002-31	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	76297-002-71	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	76297-002-01	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	76297-002-11	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	76297-002-51	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	76297-002-41	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	76297-002-21	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	76297-002-31	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	76297-002-71	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	76297-002-01	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	76297-002-11	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	76297-002-51	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	76297-002-41	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	76297-002-21	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	76297-002-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	76297-002-71	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	76297-002-01	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	76297-002-11	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	76297-002-51	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	76297-002-41	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	76297-002-21	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	76297-002-31	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	76297-002-71	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	76297-002-01	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	76297-002-11	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	76297-002-51	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	76297-002-41	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	76297-002-21	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	76297-002-31	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	76297-002-71	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	76297-002-01	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	76297-002-11	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	76297-002-51	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	76297-002-41	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	76297-002-21	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	76297-002-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	76297-002-71	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	76297-002-01	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	76297-002-11	`68b1e3bced9e…`	`98a755eb8bc6…`

Additional Listing Data#

Finished product: No
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
WATER	1 mL/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fac74f96-3910-44b9-8551-036880fbb1fb	Product name	1	20260108
0a18eae4-4259-42db-86b6-915f66e83b06	Product name	1	20250729
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
2c999b01-2a13-4eff-8eb4-00b87316ef79	Product name	1	20231116
05193eb6-d122-ab0b-603b-d9dd92599836	Product name	2	20210204
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
2e5437ef-ff80-c9c2-2f66-5b7c771080be	Product name	9	20180201
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
ae28a785-50d8-477d-a268-dffdfdd7504b	Product name	1	20150305
0c878822-66ca-456d-c17d-0894b04fa473	Product name	1	20140508
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
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#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
factor ix complex	ACTIVE INGREDIENT	FW411QXD5M	PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]	15
factor ix complex	ACTIVE MOIETY	FW411QXD5M	PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]	15
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]	15
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]	15
sodium phosphate	INACTIVE INGREDIENT	SE337SVY37	PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]	15
Alpha-1-proteinase Inhibitor Human	ACTIVE INGREDIENT	F43I396OIS	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13
Alpha-1-proteinase Inhibitor Human	ACTIVE MOIETY	F43I396OIS	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13
Sodium Phosphate	INACTIVE INGREDIENT	SE337SVY37	PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC]	13
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX	ACTIVE INGREDIENT	5T6B772R4Q	ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]	12
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX	ACTIVE MOIETY	5T6B772R4Q	ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]	12
albumin (human)	INACTIVE INGREDIENT	ZIF514RVZR	ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]	12
arginine	INACTIVE INGREDIENT	94ZLA3W45F	ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]	12
histidine	INACTIVE INGREDIENT	4QD397987E	ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]	12
Antihemophilic Factor Human	ACTIVE INGREDIENT	839MOZ74GK	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Antithrombin Iii Human	ACTIVE INGREDIENT	T0LTO7L82X	THROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]	11
Antihemophilic Factor Human	ACTIVE MOIETY	839MOZ74GK	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Antithrombin Iii Human	ACTIVE MOIETY	T0LTO7L82X	THROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]	11
Albumin (human)	INACTIVE INGREDIENT	ZIF514RVZR	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Aluminum	INACTIVE INGREDIENT	CPD4NFA903	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Calcium Chloride	INACTIVE INGREDIENT	M4I0D6VV5M	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Glycine	INACTIVE INGREDIENT	TE7660XO1C	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Histidine	INACTIVE INGREDIENT	4QD397987E	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
Tri-n-butyl Phosphate	INACTIVE INGREDIENT	95UAS8YAF5	KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC]	11
COAGULATION FACTOR IX HUMAN	ACTIVE INGREDIENT	6U90Y1795T	ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]	10
Coagulation Factor IX Human	ACTIVE MOIETY	6U90Y1795T	ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]	10
dextrose	INACTIVE INGREDIENT	IY9XDZ35W2	ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]	10
heparin	INACTIVE INGREDIENT	T2410KM04A	ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]	10
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]	10
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
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 table
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 table
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
76297-002-02	76297000202	5 mL in 1 VIAL, GLASS	5 ml		Historical
76297-002-11	76297000211	77 VIAL in 1 CASE (76297-002-11) / 10 mL in 1 VIAL	77 vial	04-FEB-16	Current
76297-002-12	76297000212	10 mL in 1 VIAL, GLASS	10 ml		Historical
76297-002-21	76297000221	40 VIAL in 1 CASE (76297-002-21) / 20 mL in 1 VIAL	40 vial	04-FEB-16	Current
76297-002-22	76297000222	20 mL in 1 VIAL, SINGLE-DOSE	20 ml		Historical
76297-002-31	76297000231	42 VIAL in 1 CASE (76297-002-31) / 30 mL in 1 VIAL	42 vial	04-FEB-16	Current
76297-002-41	76297000241	30 VIAL in 1 CASE (76297-002-41) / 40 mL in 1 VIAL	30 vial	04-FEB-16	Current
76297-002-51	76297000251	30 VIAL in 1 CASE (76297-002-51) / 50 mL in 1 VIAL	30 vial	04-FEB-16	Current
76297-002-71	76297000271	40 VIAL in 1 CASE (76297-002-71) / 15 mL in 1 VIAL	40 vial	11-DEC-20	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Factor IX Complex Profilnine ®	GRIFOLS USA, LLC \| Grifols Biologicals LLC \| LABORATORIOS GRIFOLS SA	2026-04-01	PLASMA DERIVATIVE	33
THROMBATE III	GRIFOLS USA, LLC \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	2025-08-21	PLASMA DERIVATIVE	31
AlphaNine SD	GRIFOLS USA, LLC \| Grifols Biologicals LLC \| LABORATORIOS GRIFOLS SA	2025-05-27	PLASMA DERIVATIVE	25
Alphanate	GRIFOLS USA, LLC \| Grifols Biologicals LLC \| LABORATORIOS GRIFOLS SA	2025-05-22	PLASMA DERIVATIVE	26
Koate	KEDRION BIOPHARMA, INC. \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	2023-12-13	PLASMA DERIVATIVE	10
Koate	KEDRION BIOPHARMA, INC. \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	2023-12-12	PLASMA DERIVATIVE	23
PROLASTIN-C	GRIFOLS USA, LLC \| GRIFOLS THERAPEUTICS LLC \| LABORATORIOS GRIFOLS SA	2022-02-25	PLASMA DERIVATIVE	25