Ampicillin
- Product NDC
- 43858-111
- 11-digit product format
- 438580111
- Labeler code
- 43858
- Product ID
- 43858-111_70093531-e996-4d0c-b5d0-9b74a8af713d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ampicillin sodium
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Sandoz GmbH
- Application
- ANDA061395
- Marketing category
- ANDA
- Marketing start
- 1971-03-03
- Marketing end
- 0000-00-00
- Substance
- AMPICILLIN SODIUM
- Active strength
- 250 mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC],Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A061395-001 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | |
| A061395-002 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | |
| A061395-003 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | |
| A061395-004 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | |
| A061395-005 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | |
| A061395-006 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A061395-001 | AP |
| A061395-002 | AP |
| A061395-003 | AP |
| A061395-004 | AP |
| A061395-005 | AP |
| A061395-006 | 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 | 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 | A061395-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A061395-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A061395-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A061395-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A061395-005 | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A061395-006 | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A061395-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A061395-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A061395-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A061395-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A061395-005 | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A061395-006 | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A061395-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A061395-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A061395-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A061395-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A061395-005 | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A061395-006 | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061395-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061395-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061395-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061395-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061395-005 | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061395-006 | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A061395-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A061395-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A061395-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A061395-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A061395-005 | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A061395-006 | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061395-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061395-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061395-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061395-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061395-005 | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061395-006 | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061395-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061395-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061395-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061395-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A061395-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A061395-002 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A061395-003 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A061395-004 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A061395-005 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A061395-006 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A061395-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A061395-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A061395-003 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A061395-004 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A061395-005 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A061395-006 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A061395-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A061395-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A061395-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A061395-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A061395-005 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A061395-006 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061395-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061395-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061395-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061395-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061395-005 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061395-006 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A061395-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A061395-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A061395-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A061395-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A061395-005 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A061395-006 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061395-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061395-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061395-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061395-004 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061395-005 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061395-006 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061395-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061395-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061395-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061395-004 | AP | 1 | b8a1b40f171c… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 | AMPICILLIN SODIUM | Sandoz Inc | 64a04e8c-8f78-46b3-8f45-56ef225a4f74 | 2025-02-21 | Warnings, Adverse reactions | 061395 ANDA061395 |
| Ampicillin | AMPICILLIN SODIUM | Sandoz Inc | c2908a44-1da4-4885-ae5a-23f69189d91a | 2024-10-31 | Warnings, Adverse reactions | 061395 ANDA061395 |
| Ampicillin | AMPICILLIN SODIUM | Sandoz Inc | b371e1a5-1fef-4df2-8940-c4fc02b9e2f0 | 2024-10-31 | Warnings, Adverse reactions | 061395 ANDA061395 |
| Ampicillin | AMPICILLIN SODIUM | Sandoz Inc | 5308ddfa-4a5b-4f7b-83ce-9d1b528e050d | 2024-05-09 | Warnings, Adverse reactions | 061395 ANDA061395 |
| Ampicillin | AMPICILLIN SODIUM | Sandoz Inc | 6632a5bd-45f1-422f-80b0-46e5a628969a | 2024-05-08 | Warnings, Adverse reactions | 061395 ANDA061395 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 43858-111-95 | 43858011195 | 10 VIAL, GLASS in 1 PACKAGE (43858-111-95) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (43858-111-78) | 2017-08-15 | 0000-00-00 | No | No | Current |