AMPICILLIN
- Product NDC
- 52584-082
- Requested package NDC
- 52584-082-10
- 11-digit product format
- 525840082
- Labeler code
- 52584
- Product ID
- 52584-082_f95e0226-4a5c-45cc-9b8e-0b26c6b7f5bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMPICILLIN SODIUM
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- General Injectables and Vaccines, Inc.
- Application
- ANDA065499
- Marketing category
- ANDA
- Marketing start
- 2018-10-10
- Marketing end
- 2023-10-31
- Substance
- AMPICILLIN SODIUM
- Active strength
- 1 g/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 52584-082 | 52584-082-10 | D | Discontinued by firm | 2026-08-11 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065499-001 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2010-08-17 | ||
| A065499-002 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | |
| A065499-003 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | |
| A065499-004 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | |
| A065499-005 | AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065499-002 | AP |
| A065499-003 | AP |
| A065499-004 | AP |
| A065499-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A065499-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2010-08-17 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065499-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065499-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065499-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065499-005 | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065499-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2010-08-17 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065499-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065499-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065499-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065499-005 | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065499-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2010-08-17 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065499-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065499-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065499-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065499-005 | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065499-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2010-08-17 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065499-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065499-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065499-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065499-005 | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065499-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2010-08-17 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065499-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065499-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065499-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065499-005 | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065499-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2010-08-17 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065499-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065499-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065499-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065499-005 | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065499-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2010-08-17 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065499-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065499-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065499-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065499-005 | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065499-001 | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 2010-08-17 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065499-002 | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065499-003 | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065499-004 | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065499-005 | AMPICILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2010-08-17 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A065499-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065499-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065499-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065499-005 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065499-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065499-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065499-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065499-005 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065499-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065499-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065499-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065499-005 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065499-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065499-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065499-004 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065499-005 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065499-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065499-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065499-004 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065499-005 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065499-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065499-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065499-004 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065499-005 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065499-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065499-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065499-004 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065499-005 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065499-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065499-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065499-004 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065499-005 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065499-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065499-003 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065499-004 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065499-005 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065499-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065499-003 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065499-004 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065499-005 | AP | 1 | d06236e962d9… |
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 | Henry Schein, Inc. | 78988f6a-a73b-4d3b-9a76-d61a748c3c16 | 2026-07-31 | Warnings, Adverse reactions | 065499 ANDA065499 |
| AMPICILLIN | AMPICILLIN SODIUM | Henry Schein, Inc. | 06ca924c-5f3a-4924-90f4-5ba623daaa0e | 2026-04-30 | Warnings, Adverse reactions | 065499 ANDA065499 |
| Ampicillin | AMPICILLIN SODIUM | Eugia US LLC | b7bf2897-8272-4c7d-84e9-6fbba0ea63fa | 2025-08-14 | Warnings, Adverse reactions | 065499 ANDA065499 |
| Ampicillin | AMPICILLIN SODIUM | ProPharma Distribution | 364b1db9-e523-7bae-e063-6294a90a651d | 2025-07-18 | Warnings, Adverse reactions | 065499 ANDA065499 |
| AMPICILLIN | AMPICILLIN | HF Acquisition Co LLC, DBA HealthFirst | e51db6a3-027a-6e24-e053-2a95a90a1587 | 2024-01-14 | Warnings, Adverse reactions | 065499 ANDA065499 |
| Ampicillin | AMPICILLIN SODIUM | Medical Purchasing Solutions, LLC | 690f1986-6da9-4787-e053-2a91aa0a2644 | 2023-05-23 | Warnings, Adverse reactions | 065499 ANDA065499 |
| Ampicillin | AMPICILLIN SODIUM | Medical Purchasing Solutions, LLC | 70c022b0-ac9a-409b-e053-2a91aa0a757e | 2023-05-22 | Warnings, Adverse reactions | 065499 ANDA065499 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52584-082-10 | 52584008210 | 1 VIAL in 1 BAG (52584-082-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 1 vial | 2018-10-10 | 2023-10-31 | No | No | Current |