Home NDC 70771-1943 Ascorbic acid
Product NDC 70771-1943
11-digit product format 707711943
Labeler code 70771
Product ID 70771-1943_db495704-ebb9-4090-b28a-b30b73e10ffa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ascorbic acid
Dosage form INJECTION
Route INTRAVENOUS
Labeler Zydus Lifesciences Limited
Application ANDA220873
Marketing category ANDA
Marketing start 2026-09-28
Substance ASCORBIC ACID
Active strength 500 mg/mL
Pharmacologic classes Ascorbic Acid [CS], Vitamin C [EPC]
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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220873-001 ASCORBIC ACID ASCORBIC ACID 2,500MG/5ML (500MG/ML) SOLUTION / INTRAVENOUS RS 2026-08-20 A220873-002 ASCORBIC ACID ASCORBIC ACID 5,000MG/10ML (500MG/ML) SOLUTION / INTRAVENOUS RS 2026-08-20 A220873-003 ASCORBIC ACID ASCORBIC ACID 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS AP 2026-08-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220873-003 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.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A220873-001 ASCORBIC ACID 2,500MG/5ML (500MG/ML) SOLUTION / INTRAVENOUS RS 2026-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220873-002 ASCORBIC ACID 5,000MG/10ML (500MG/ML) SOLUTION / INTRAVENOUS RS 2026-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220873-003 ASCORBIC ACID 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS AP 2026-08-20 84e616aacf4f…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A220873-003 AP 1 84e616aacf4f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ascorbic acid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASCORBIC ACID 500 mg/mL
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70771-1943-8 70771194308 1 VIAL, GLASS in 1 CARTON (70771-1943-8) / 5 mL in 1 VIAL, GLASS 2026-09-28 No No Current 70771-1943-9 70771194309 25 VIAL, GLASS in 1 CARTON (70771-1943-9) / 5 mL in 1 VIAL, GLASS 2026-09-28 No No Current