Ampicillin
- Product NDC
- 0781-3404
- 11-digit product format
- 007813404
- Labeler code
- 0781
- Product ID
- 0781-3404_2cc1b620-59dd-4d45-8edf-af20bdd82ee5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ampicillin sodium
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Sandoz Inc
- Application
- ANDA061395
- Marketing category
- ANDA
- Marketing start
- 1971-03-03
- Substance
- AMPICILLIN SODIUM
- Active strength
- 1 g/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS]
- 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061395-005 | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061395-006 | AMPICILLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061395-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061395-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061395-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061395-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS, Approved before 1982 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061395-005 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061395-006 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061395-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061395-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061395-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061395-004 | AP | 1 | 03ed91905a0d… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ampicillin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMPICILLIN SODIUM | 1 g/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| JFN36L5S8K | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 64a04e8c-8f78-46b3-8f45-56ef225a4f74 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fd9d6ee0-43ae-43c7-aa52-3d5a936186d6 | Product name | 1 | 20250722 |
| 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 |
|---|---|---|---|---|---|---|
| 0781-3404-85 | Ampicillin | 1 in 1 VIAL, GLASS | INJECTION, POWDER, FOR SOLUTION | 1 | 24 | |
| 0781-3404-95 | Ampicillin | 10 in 1 PACKAGE | INJECTION, POWDER, FOR SOLUTION | 10 | 24 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-3404-85 | EA - Each | 0781-3404 | 4d7253ab-d1b7-4283-b748-46bcf30f62b8 | 1 | 2012-07-24 |
| 0781-3404-95 | EA - Each | 0781-3404 | 92b529a2-8989-4b14-b0d7-2f9e2a0d0941 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| AMPICILLIN SODIUM | ACTIVE INGREDIENT | JFN36L5S8K | AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] | 14 | |
| AMPICILLIN | ACTIVE MOIETY | 7C782967RD | AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] | 14 |
DailyMed Dashboard NDC Coverage#
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 0781-3404 |
| 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 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0781-3404-85 | 00781340485 | 1 in 1 VIAL, GLASS | Historical | ||||
| 0781-3404-95 | 00781340495 | 10 VIAL, GLASS in 1 PACKAGE (0781-3404-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (0781-3404-85) | 1971-03-03 | 0000-00-00 | No | No | Current |