FDA.reportPublic FDA data

ASCORBIC ACID injection, for intravenous use

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-09-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-30 01:02:41

Label at a glance#

ProductAscorbic acid
Active ingredientASCORBIC ACID
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ascorbic Acid Injection, USP

2,500 mg/5 mL (500 mg/mL)

NDC 70771-1943-1

Rx Only

2500 mg label
2500 mg label

Ascorbic Acid Injection, USP

5,000 mg/10 mL (500 mg/mL)

NDC 70771-1944-1

Rx Only

5000 mg label
5000 mg label

Ascorbic Acid Injection, USP

25,000 mg/50 mL (500 mg/mL)

NDC 70771-1945-1

Rx Only

25000 mg label
25000 mg label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130370710216412GTIN-13: 0370710216412
EAN-13: 0370710216412
GTIN-12: 370710216412
UPC-A: 370710216412
GTIN storage (14 digits): 00370710216412		db495704-ebb9-4090-b28a-b30b73e10ffa-03.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-194370771-1943-8, 70771-1943-9
70771-194470771-1944-8, 70771-1944-9
70771-194570771-1945-8, 70771-1945-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASCORBIC ACIDPQ6CK8PD0RACTIB
EDETATE DISODIUM7FLD91C86KIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM HYDROXIDE55X04QC32IIACT
ASCORBIC ACIDPQ6CK8PD0RACTIB
EDETATE DISODIUM7FLD91C86KIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM HYDROXIDE55X04QC32IIACT
ASCORBIC ACIDPQ6CK8PD0RACTIB
EDETATE DISODIUM7FLD91C86KIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220873-001ASCORBIC ACIDASCORBIC ACID2,500MG/5ML (500MG/ML)SOLUTION / INTRAVENOUSRS2026-08-20
A220873-002ASCORBIC ACIDASCORBIC ACID5,000MG/10ML (500MG/ML)SOLUTION / INTRAVENOUSRS2026-08-20
A220873-003ASCORBIC ACIDASCORBIC ACID25,000MG/50ML (500MG/ML)SOLUTION / INTRAVENOUSAP2026-08-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A220873-003AP

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
2026-09-14 22:38:342026-08A220873-001ASCORBIC ACID2,500MG/5ML (500MG/ML)SOLUTION / INTRAVENOUSRS2026-08-2084e616aacf4f…
2026-09-14 22:38:342026-08A220873-002ASCORBIC ACID5,000MG/10ML (500MG/ML)SOLUTION / INTRAVENOUSRS2026-08-2084e616aacf4f…
2026-09-14 22:38:342026-08A220873-003ASCORBIC ACID25,000MG/50ML (500MG/ML)SOLUTION / INTRAVENOUSAP2026-08-2084e616aacf4f…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A220873-003AP184e616aacf4f…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ascorbic AcidASCORBIC ACIDRenova Pharmaceuticals LLCa6481bae-2397-44c7-a51d-4f47ad91bd2c2026-08-19Warnings, Adverse reactionsName fallback
brand name: Ascorbic Acid
generic name: ASCORBIC ACID
AscorASCORBIC ACIDMcGuff Pharmaceuticals, Inc.388aad52-fc01-4784-9791-1dbc80c693062026-05-29Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
Ascorbic AcidASCORBIC ACIDFresenius Kabi USA, LLC1606e29f-0e80-4069-b688-daab9cbff20a2025-12-17Warnings, Adverse reactionsName fallback
brand name: Ascorbic Acid
generic name: ASCORBIC ACID
Skin Renewing SerumASCORBIC ACIDGuangzhou Danting Bath&Body Care Industry Co. Ltd396c2a8d-ac95-cbef-e063-6294a90aff392025-08-23WarningsName fallback
generic name: ASCORBIC ACID

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.