FDA.reportPublic FDA data

Ascorbic Acid

Product NDC
65219-027
11-digit product format
652190027
Labeler code
65219
Product ID
65219-027_d6fd1a37-70e1-477a-afc9-4977a54c7b75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ascorbic Acid
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA217131
Marketing category
ANDA
Marketing start
2025-12-08
Substance
ASCORBIC ACID
Active strength
500 mg/mL
Pharmacologic classes
Ascorbic Acid [CS], Vitamin C [EPC]
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217131-001ASCORBIC ACIDASCORBIC ACID25,000MG/50ML (500MG/ML)SOLUTION / INTRAVENOUSAP2025-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217131-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A217131-001ASCORBIC ACID25,000MG/50ML (500MG/ML)SOLUTION / INTRAVENOUSAP2025-08-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217131-001ASCORBIC ACID25,000MG/50ML (500MG/ML)SOLUTION / INTRAVENOUSAP2025-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217131-001ASCORBIC ACID25,000MG/50ML (500MG/ML)SOLUTION / INTRAVENOUSAP2025-08-0731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217131-001ASCORBIC ACID25,000MG/50ML (500MG/ML)SOLUTION / INTRAVENOUSAP2025-08-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217131-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217131-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217131-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217131-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Ascorbic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASCORBIC ACID500 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PQ6CK8PD0RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308395Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1606e29f-0e80-4069-b688-daab9cbff20aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-027-05Ascorbic Acid50 mL in 1 VIAL, GLASSINJECTION501
65219-027-50Ascorbic Acid25 in 1 TRAYINJECTION251
65219-027-55Ascorbic Acid1 in 1 CARTONINJECTION11
65219-027-55Ascorbic Acid50 mL in 1 VIAL, GLASSINJECTION501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-027-05ML - Milliliter65219-0275d17b5c2-2de0-47a2-acf1-b83f1d46f9d312026-01-08
65219-027-50ML - Milliliter65219-027c00cfdda-ab58-4106-8548-645007a1eeed12026-01-08
65219-027-55ML - Milliliter65219-0276b01e7d5-bdb1-4e25-87d3-7530404daeeb12026-03-17

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ascorbic AcidASCORBIC ACIDFresenius Kabi USA, LLC1606e29f-0e80-4069-b688-daab9cbff20a2025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217131
application number: ANDA217131
ndc (product): 65219-027

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308395ascorbic acid 500 MG/ML Injectable SolutionPSN1606e29f-0e80-4069-b688-daab9cbff20a1
308395ascorbic acid 500 MG/ML Injectable SolutionSCD1606e29f-0e80-4069-b688-daab9cbff20a1
308395vit-C 500 MG/ML Injectable SolutionSY1606e29f-0e80-4069-b688-daab9cbff20a1
308395vitamin C 500 MG/ML Injectable SolutionSY1606e29f-0e80-4069-b688-daab9cbff20a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-027-056521900270550 mL in 1 VIAL, GLASS50 mlHistorical
65219-027-506521900275025 VIAL, GLASS in 1 TRAY (65219-027-50) / 50 mL in 1 VIAL, GLASS (65219-027-05) 2025-12-08NoNoCurrent
65219-027-55652190027551 VIAL, GLASS in 1 CARTON (65219-027-55) / 50 mL in 1 VIAL, GLASS2025-12-08NoNoCurrent