Home NDC 43858-133-02 Ampicillin and Sulbactam
Product NDC 43858-133
Requested package NDC 43858-133-02
11-digit product format 438580133
Labeler code 43858
Product ID 43858-133_989a6b34-596b-4c83-88e5-efbfd4d36ee6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ampicillin sodium and Sulbactam sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Sandoz GmbH
Application ANDA065310
Marketing category ANDA
Marketing start 2006-07-25
Marketing end 0000-00-00
Substance AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength 1 g/1; g/1
Pharmacologic classes Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065310-001 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2006-07-25 A065310-002 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-07-25
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 3 · 88 observed 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 2026-10-15 13:18:30 2026-09 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2006-07-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-07-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2006-07-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-07-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2006-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2006-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2006-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43858-133-02 43858013302 10 VIAL in 1 TRAY (43858-133-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 10 vial 2017-08-25 0000-00-00 No No Current