Home NDC 83854-038-01 Bupivacaine Hydrochloride
Product NDC 83854-038
Requested package NDC 83854-038-01
11-digit product format 838540038
Labeler code 83854
Product ID 83854-038_5c9994dc-1543-ade0-e063-6294a90ae211
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupivacaine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INFILTRATION; PERINEURAL
Labeler Anthea Pharma Private Limited
Application ANDA220493
Marketing category ANDA
Marketing start 2026-04-21
Substance BUPIVACAINE HYDROCHLORIDE
Active strength 2.5 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
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 A220493-001 BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2026-04-22 A220493-002 BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2026-04-22 A220493-003 BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / INJECTION AP 2026-04-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 A220493-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2026-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220493-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2026-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220493-003 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / INJECTION AP 2026-04-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220493-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2026-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220493-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2026-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220493-003 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / INJECTION AP 2026-04-22 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220493-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 2026-04-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220493-002 BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE / INJECTION AP 2026-04-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220493-003 BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE / INJECTION AP 2026-04-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 Bupivacaine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL
DailyMed Product Concepts# DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83854-038-01 83854003801 1 VIAL in 1 CARTON (83854-038-01) / 50 mL in 1 VIAL 1 vial 2026-09-11 No No Current