Sterile Water

Product NDC: 63323-185
11-digit product format: 633230185
Labeler code: 63323
Product ID: 63323-185_42c6c812-706a-425b-b8cb-931006e40484
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: WATER
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA088400
Marketing category: ANDA
Marketing start: 2000-09-05
Substance: WATER
Active strength: 1 mL/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	STERILE WATER FOR INJECTION	100%	LIQUID / N/A	AP		1984-01-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A088400-001	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088400-001	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	100%	LIQUID / N/A	AP	1984-01-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A088400-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088400-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088400-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088400-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088400-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088400-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088400-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088400-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088400-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088400-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088400-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088400-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088400-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088400-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088400-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088400-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088400-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088400-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088400-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088400-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088400-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088400-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088400-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088400-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088400-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088400-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088400-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088400-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088400-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088400-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088400-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088400-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088400-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088400-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088400-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088400-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088400-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088400-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088400-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088400-001	AP	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sterile Water
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
WATER	1 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
059QF0KO0R	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e71c6c83-d518-496c-b2ab-efd5987e4783	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
83f7a8cc-8fbf-4478-9a44-b6214b840d9a	Product name	2	20250812
e86469f1-0431-b4e2-fe09-0dbe527624d7	Product name	2	20250804
1e832aa0-608b-424f-9ced-615cef2ff5c5	Product name	1	20200220
6ee0758f-9a1a-41ee-90c4-3adce06b52b4	Product name	1	20191120
e4138432-bbdb-43bd-8e68-9964f0048734	Product name	1	20190228
750a4794-c0e1-4ac9-9af5-006ecec3bb04	Product name	1	20150608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63323-185-04	Sterile Water	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION	5		8
63323-185-05	Sterile Water	25 in 1 TRAY	INJECTION	25		8
63323-185-07	Sterile Water	10 mL in 1 VIAL	INJECTION	10		8
63323-185-08	Sterile Water	20 mL in 1 VIAL	INJECTION	20		8
63323-185-09	Sterile Water	50 mL in 1 VIAL	INJECTION	50		8
63323-185-10	Sterile Water	25 in 1 TRAY	INJECTION	25		8
63323-185-20	Sterile Water	25 in 1 TRAY	INJECTION	25		8
63323-185-50	Sterile Water	25 in 1 TRAY	INJECTION	25		8
63323-185-03	Glucagon	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1 mL	1 mL in 1mL	7
63323-185-03	Glucagon	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1 mL	1 mL in 1mL	6
63323-185-82	Glucagon	1 mL in 1 SYRINGE, GLASS	INJECTION	1 mL	1 mL in 1mL	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-185-00	ML - Milliliter	63323-185	609372aa-98b8-4f00-9e6a-abb1487abd14	1	2014-12-01
63323-185-04	ML - Milliliter	63323-185	85267d45-614b-48e8-8d11-2af1614a79a6	1	2022-11-07
63323-185-05	ML - Milliliter	63323-185	ed5e269f-f785-44e0-a2eb-21663d2348a0	1	2014-12-01
63323-185-07	ML - Milliliter	63323-185	b87e5d9c-faa0-424c-b288-6f564ce4f34b	1	2022-02-07
63323-185-08	ML - Milliliter	63323-185	d5906835-0663-4376-979f-66773354b843	1	2022-02-07
63323-185-09	ML - Milliliter	63323-185	630fe398-09fc-473b-9503-4b65d83609e7	1	2022-02-07
63323-185-10	ML - Milliliter	63323-185	7567cc84-d09c-49ee-9540-caf963a8be9f	1	2014-11-05
63323-185-20	ML - Milliliter	63323-185	83df970a-0a1b-4537-9b6f-7128f352dd51	1	2014-11-05
63323-185-50	ML - Milliliter	63323-185	94d5c391-36bd-4b25-9b72-91f4c5d9ed45	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLUCAGON HYDROCHLORIDE	ACTIVE INGREDIENT	1H87NVF4DB	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
GLUCAGON HYDROCHLORIDE	ACTIVE INGREDIENT	1H87NVF4DB	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
Indocyanine green	ACTIVE INGREDIENT	IX6J1063HV	INDOCYANINE GREEN KIT INDOCYANINE GREEN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADAQ TECHNOLOGIES INC.]	1
WATER	ACTIVE INGREDIENT	059QF0KO0R	BACTERIOSTATIC WATER (WATER) INJECTION, SOLUTION STERILE WATER (WATER) INJECTION [FRESENIUS KABI USA, LLC]	1
GLUCAGON	ACTIVE MOIETY	76LA80IG2G	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
GLUCAGON	ACTIVE MOIETY	76LA80IG2G	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
Indocyanine green	ACTIVE MOIETY	IX6J1063HV	INDOCYANINE GREEN KIT INDOCYANINE GREEN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADAQ TECHNOLOGIES INC.]	1
WATER	ACTIVE MOIETY	059QF0KO0R	BACTERIOSTATIC WATER (WATER) INJECTION, SOLUTION STERILE WATER (WATER) INJECTION [FRESENIUS KABI USA, LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BACTERIOSTATIC WATER (WATER) INJECTION, SOLUTION STERILE WATER (WATER) INJECTION [FRESENIUS KABI USA, LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BACTERIOSTATIC WATER (WATER) INJECTION, SOLUTION STERILE WATER (WATER) INJECTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
sodium iodide	INACTIVE INGREDIENT	F5WR8N145C	INDOCYANINE GREEN KIT INDOCYANINE GREEN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADAQ TECHNOLOGIES INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-185	STERILE WATER (WATER) INJECTION [FRESENIUS KABI USA, LLC]	8	Current NDC, Legacy NDC, 8 package rows	20220624_e71c6c83-d518-496c-b2ab-efd5987e4783.zip
63323-185	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GLUCAGON KIT [FRESENIUS KABI USA, LLC]	7	Current NDC, Legacy NDC	20211118_e4be1c0e-0fe6-45a0-9229-5cde98434b84.zip
63323-185	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GLUCAGON KIT [FRESENIUS KABI USA, LLC]	6	Current NDC, Legacy NDC	20220420_8c8acad6-44cc-43aa-966b-027e053be8f5.zip
63323-185	GLUCAGON (GLUCAGON) KIT [FRESENIUS KABI USA, LLC]	5	Current NDC, Legacy NDC	20250402_c5c431b4-5618-4ff4-954e-4c0fbfed67b6.zip
63323-185	INDOCYANINE GREEN KIT INDOCYANINE GREEN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADAQ TECHNOLOGIES INC.]	1	Current NDC, Legacy NDC	20111201_c1031b17-b6e3-4153-869f-30d9c7e66bc3.zip

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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	Cardinal Health 107, LLC	48d75a7c-8329-48a8-bea0-a8c144ddf637	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088400 application number: ANDA088400
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088400 application number: ANDA088400
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088400 application number: ANDA088400 ndc (product): 63323-185

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
059QF0KO0R	WATER	7732-18-5	WATER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310497	glucagon (rDNA) 1 MG Injection	PSN	e4be1c0e-0fe6-45a0-9229-5cde98434b84	7
310497	glucagon (rDNA) 1 MG Injection	SCD	e4be1c0e-0fe6-45a0-9229-5cde98434b84	7
310497	glucagon (rDNA) 1 MG Injection	PSN	8c8acad6-44cc-43aa-966b-027e053be8f5	6
310497	glucagon (rDNA) 1 MG Injection	SCD	8c8acad6-44cc-43aa-966b-027e053be8f5	6
310497	glucagon (rDNA) 1 MG Injection	PSN	c5c431b4-5618-4ff4-954e-4c0fbfed67b6	5
310497	glucagon (rDNA) 1 MG Injection	SCD	c5c431b4-5618-4ff4-954e-4c0fbfed67b6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-185-00	63323018500	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-00) > 100 mL in 1 VIAL, SINGLE-DOSE		2000-09-05	0000-00-00	No	No	Current
63323-185-03	63323018503	1 mL in 1 VIAL, SINGLE-DOSE	1 ml					Historical
63323-185-04	63323018504	5 mL in 1 VIAL, SINGLE-DOSE	5 ml					Historical
63323-185-05	63323018505	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-185-04)		2022-04-30	0000-00-00	No	No	Current
63323-185-07	63323018507	10 mL in 1 VIAL	10 ml					Historical
63323-185-08	63323018508	20 mL in 1 VIAL	20 ml					Historical
63323-185-09	63323018509	50 mL in 1 VIAL	50 ml					Historical
63323-185-10	63323018510	25 VIAL in 1 TRAY (63323-185-10) / 10 mL in 1 VIAL (63323-185-07)	25 vial	2000-09-05	0000-00-00	No	No	Current
63323-185-20	63323018520	25 VIAL in 1 TRAY (63323-185-20) / 20 mL in 1 VIAL (63323-185-08)	25 vial	2000-09-05	0000-00-00	No	No	Current
63323-185-50	63323018550	25 VIAL in 1 TRAY (63323-185-50) / 50 mL in 1 VIAL (63323-185-09)	25 vial	2000-09-05	0000-00-00	No	No	Current
63323-185-82	63323018582	1 mL in 1 SYRINGE, GLASS	1 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sterile Water for Injection, USP	Cardinal Health 107, LLC	2025-11-05	HUMAN PRESCRIPTION DRUG LABEL	2
Glucagon	Fresenius Kabi USA, LLC	2025-03-31	HUMAN PRESCRIPTION DRUG LABEL	5
Sterile Water for Injection, USP	Fresenius Kabi USA, LLC	2022-06-09	HUMAN PRESCRIPTION DRUG LABEL	8
Glucagon	Fresenius Kabi USA, LLC	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	6
Glucagon	Fresenius Kabi USA, LLC	2020-09-16	HUMAN PRESCRIPTION DRUG LABEL	7
Sterile Water for Injection USP-Bacteriostatic Water for Injection USP	Fresenius Kabi USA, LLC	2020-06-26	Human Prescription Drug Label	4
Indocyanine Green for Injection USP	Novadaq Technologies Inc.	2011-11-18	HUMAN PRESCRIPTION DRUG LABEL	1