AQUASOL A Parenteral

Product NDC: 64980-721
11-digit product format: 649800721
Labeler code: 64980
Product ID: 64980-721_0c90883f-68ce-459d-8239-4e96e0b49c80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Water-Miscible Retinyl Palmitate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Rising Pharma Holdings, Inc.
Application: NDA006823
Marketing category: NDA
Marketing start: 2026-02-27
Substance: VITAMIN A PALMITATE
Active strength: 15 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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
N006823-001	AQUASOL A	VITAMIN A PALMITATE	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982

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	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N006823-001	AQUASOL A	EQ 50,000 UNITS BASE/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: AQUASOL A Parenteral
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VITAMIN A PALMITATE	15 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1D1K0N0VVC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
210972	Internal RxNorm lookup
313650	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
1abd66eb-6ac8-4a9e-a609-251e46ea1a27	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64980-721-02	AQUASOL A Parenteral	1 in 1 CARTON	INJECTION, SOLUTION	1		1
64980-721-02	AQUASOL A Parenteral	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-721-02	ML - Milliliter	64980-721	5cf62cf5-5a4e-4063-9fa0-84bf422b35e2	1	2026-05-22

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AQUASOL A Parenteral	WATER-MISCIBLE RETINYL PALMITATE	Rising Pharma Holdings, Inc.	1abd66eb-6ac8-4a9e-a609-251e46ea1a27	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 006823 application number: NDA006823 ndc (product): 64980-721

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1D1K0N0VVC	VITAMIN A PALMITATE	79-81-2	VITAMIN A PALMITATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
210972	Aquasol A 50,000 UNT/ML in 2 ML Injection	PSN	1abd66eb-6ac8-4a9e-a609-251e46ea1a27	1
313650	vitamin A 50,000 UNT/ML in 2 ML Injection	PSN	1abd66eb-6ac8-4a9e-a609-251e46ea1a27	1
210972	2 ML vitamin A 50000 UNT/ML Injection [Aquasol A]	SBD	1abd66eb-6ac8-4a9e-a609-251e46ea1a27	1
313650	2 ML vitamin A 50000 UNT/ML Injection	SCD	1abd66eb-6ac8-4a9e-a609-251e46ea1a27	1
210972	Aquasol A 50,000 UNT/ML (as retinol 15 MG/ML) per 2 ML Injection	SY	1abd66eb-6ac8-4a9e-a609-251e46ea1a27	1
210972	Aquasol A 50,000 UNT/ML per 2 ML Injection	SY	1abd66eb-6ac8-4a9e-a609-251e46ea1a27	1
313650	vitamin A (as retinyl palmitate) 50,000 UNT/mL per 2 mL Injection	SY	1abd66eb-6ac8-4a9e-a609-251e46ea1a27	1
313650	vitamin A 50,000 UNT/ML per 2 ML Injection	SY	1abd66eb-6ac8-4a9e-a609-251e46ea1a27	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
64980-721-02	64980072102	1 VIAL, SINGLE-DOSE in 1 CARTON (64980-721-02) / 2 mL in 1 VIAL, SINGLE-DOSE	2026-02-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AQUASOL A ® Parenteral	Rising Pharma Holdings, Inc. \| Maiva Pharma Private Limited	2026-03-03	Human Prescription Drug Label	1