Home NDC 0049-0014 UNASYN
Product NDC 0049-0014
11-digit product format 000490014
Labeler code 0049
Product ID 0049-0014_6b0299f2-a683-4c8f-bf62-b79d5f652b41
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ampicillin sodium and sulbactam sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Roerig
Application NDA050608
Marketing category NDA
Marketing start 1991-11-22
Substance AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength 2; 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 2026-12-31
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050608-001 UNASYN AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 N050608-002 UNASYN AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 N050608-003 UNASYN AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION 1986-12-31 N050608-005 UNASYN AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-12-10
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.
Product history page 1 of 5 · 172 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 2026-09-14 22:38:34 2026-08 N050608-001 UNASYN EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050608-002 UNASYN EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050608-003 UNASYN EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION 1986-12-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050608-005 UNASYN EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-12-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050608-001 UNASYN EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050608-002 UNASYN EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050608-003 UNASYN EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION 1986-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050608-005 UNASYN EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050608-001 UNASYN EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050608-002 UNASYN EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050608-003 UNASYN EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION 1986-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050608-005 UNASYN EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050608-001 UNASYN EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050608-002 UNASYN EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050608-003 UNASYN EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION 1986-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050608-005 UNASYN EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050608-001 UNASYN EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050608-002 UNASYN EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050608-003 UNASYN EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION 1986-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050608-005 UNASYN EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050608-001 UNASYN EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050608-002 UNASYN EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050608-003 UNASYN EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION 1986-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050608-005 UNASYN EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050608-001 UNASYN EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050608-002 UNASYN EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050608-003 UNASYN EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION 1986-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050608-005 UNASYN EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050608-001 UNASYN EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050608-002 UNASYN EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050608-003 UNASYN EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION 1986-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050608-005 UNASYN EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050608-001 UNASYN EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050608-002 UNASYN EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050608-003 UNASYN EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION 1986-12-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050608-005 UNASYN EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050608-001 UNASYN EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050608-002 UNASYN EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1986-12-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050608-003 UNASYN EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL INJECTABLE / INJECTION 1986-12-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050608-005 UNASYN EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1993-12-10 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Additional Listing Data#
Finished product Yes
Brand name base UNASYN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPICILLIN SODIUM 2 g/1 SULBACTAM SODIUM 1 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DKQ4T82YE6 Internal UNII lookup JFN36L5S8K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1659592 Internal RxNorm lookup 1659595 Internal RxNorm lookup 1659598 Internal RxNorm lookup 1659600 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0049-0014-81 UNASYN 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 45 0049-0014-83 UNASYN 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 45
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMPICILLIN SODIUM ACTIVE INGREDIENT JFN36L5S8K UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG] 13 SULBACTAM SODIUM ACTIVE INGREDIENT DKQ4T82YE6 UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG] 13 AMPICILLIN ACTIVE MOIETY 7C782967RD UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG] 13 SULBACTAM ACTIVE MOIETY S4TF6I2330 UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG] 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0049-0014 UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG] 45 Current NDC, Legacy NDC, 2 package rows 20250515_155c7ec0-5862-404f-b1d0-f278f8a8bbda.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0049-0014-81 00049001481 1 in 1 VIAL Historical 0049-0014-83 00049001483 10 VIAL in 1 CARTON (0049-0014-83) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0014-81) 10 vial 1991-11-22 0000-00-00 No No Current