Ampicillin and Sulbactam
- Product NDC
- 55150-179
- Requested package NDC
- 55150-179-99
- 11-digit product format
- 551500179
- Labeler code
- 55150
- Product ID
- 55150-179_13813cd5-ff90-48a1-97d4-3a0f1db1fb45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ampicillin Sodium and Sulbactam Sodium
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA090340
- Marketing category
- ANDA
- Marketing start
- 2012-09-13
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090340-001 | AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | ||
| A090340-002 | AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 |
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 | 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 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 2010-09-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-09-20 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-09-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-09-20 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-09-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090340-001 | AMPICILLIN AND SULBACTAM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-09-20 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090340-002 | AMPICILLIN AND SULBACTAM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-09-20 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-04-08 23:34 UTC | 2022-04 | A090340-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090340-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090340-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090340-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090340-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090340-002 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090340-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090340-002 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090340-001 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090340-002 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090340-001 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090340-002 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090340-001 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090340-002 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090340-001 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090340-002 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090340-001 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090340-002 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090340-001 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A090340-002 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090340-001 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090340-002 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090340-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090340-002 | AP | 1 | ea99ee380514… |
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
- Ampicillin and Sulbactam
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMPICILLIN SODIUM | 2 g/1 |
| SULBACTAM SODIUM | 1 g/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| JFN36L5S8K | Internal UNII lookup |
| DKQ4T82YE6 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| adc92303-b62b-41c8-becf-9c3a4e8c3a6b | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fd9d6ee0-43ae-43c7-aa52-3d5a936186d6 | Product name | 1 | 20250722 |
| 1f6437d4-fe6e-4912-889c-84576c1da4d8 | Product name | 1 | 20231019 |
| 4fe9b92f-7dcd-4058-8def-e75f4dcd5ab3 | Product name | 2 | 20160201 |
| c9385d77-2af7-47a4-bc97-1127e71caf9b | Product name | 3 | 20160201 |
| 05b6b9ae-4ba4-27ee-4c8c-f72b41de3815 | Product name | 5 | 20151207 |
| b353113e-7b3d-4b1f-a286-b96a3a5eac85 | Product name | 3 | 20151026 |
| 8c59be9b-72b0-49e8-b7ef-1a80c10599de | Product name | 3 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55150-179-99 | Ampicillin and Sulbactam | 10 in 1 BOX | INJECTION, POWDER, FOR SOLUTION | 10 | 11 | |
| 55150-179-99 | Ampicillin and Sulbactam | 1 in 1 BOTTLE | INJECTION, POWDER, FOR SOLUTION | 1 | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55150-179 | AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240612_adc92303-b62b-41c8-becf-9c3a4e8c3a6b.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ampicillin and Sulbactam | AMPICILLIN SODIUM AND SULBACTAM SODIUM | Eugia US LLC | adc92303-b62b-41c8-becf-9c3a4e8c3a6b | 2025-08-12 | Warnings, Adverse reactions | 090340 ANDA090340 55150-179-99 55150-179 55150017999 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1659592 | ampicillin / sulbactam 1.5 GM Injection | PSN | adc92303-b62b-41c8-becf-9c3a4e8c3a6b | 11 |
| 1659598 | ampicillin / sulbactam 3 GM Injection | PSN | adc92303-b62b-41c8-becf-9c3a4e8c3a6b | 11 |
| 1659592 | ampicillin 1000 MG / sulbactam 500 MG Injection | SCD | adc92303-b62b-41c8-becf-9c3a4e8c3a6b | 11 |
| 1659598 | ampicillin 2000 MG / sulbactam 1000 MG Injection | SCD | adc92303-b62b-41c8-becf-9c3a4e8c3a6b | 11 |
| 1659592 | ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM Injection | SY | adc92303-b62b-41c8-becf-9c3a4e8c3a6b | 11 |
| 1659598 | ampicillin (as ampicillin sodium) 2 GM / sulbactam (as sulbactam sodium) 1 GM Injection | SY | adc92303-b62b-41c8-becf-9c3a4e8c3a6b | 11 |
| 1659592 | ampicillin 1 GM / sulbactam 0.5 GM Injection | SY | adc92303-b62b-41c8-becf-9c3a4e8c3a6b | 11 |
| 1659598 | ampicillin 2 GM / sulbactam 1 GM Injection | SY | adc92303-b62b-41c8-becf-9c3a4e8c3a6b | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55150-179-99 | 55150017999 | 10 BOTTLE in 1 BOX (55150-179-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE | 10 bottle | 2012-09-13 | 0000-00-00 | No | No | Current |