Ceftriaxone
- Product NDC
- 70518-0601
- 11-digit product format
- 705180601
- Labeler code
- 70518
- Product ID
- 70518-0601_531f7f3b-15e9-128e-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ceftriaxone
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA065230
- Marketing category
- ANDA
- Marketing start
- 2017-06-29
- Marketing end
- 0000-00-00
- Substance
- CEFTRIAXONE SODIUM
- Active strength
- 250 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 product | product | 70518-0601 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 70518-0601 | 70518-0601-0 | D | Discontinued by firm | 2026-10-05 |
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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-0601-0 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-0601-0 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-0601-0 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-0601-0 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-0601-0 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-0601-0 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-0601-0 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-0601-0 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-0601-0 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-0601-0 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-0601-0 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-0601-0 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 70518-0601-0 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065230-001 | CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | ||
| A065230-002 | CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | ||
| A065230-003 | CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | ||
| A065230-004 | CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 |
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 | A065230-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A065230-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A065230-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A065230-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065230-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065230-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065230-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065230-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065230-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065230-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065230-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065230-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065230-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065230-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065230-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065230-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065230-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065230-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065230-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065230-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065230-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065230-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065230-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065230-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065230-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065230-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065230-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065230-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065230-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065230-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065230-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065230-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065230-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065230-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065230-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065230-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065230-001 | CEFTRIAXONE | EQ 250MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065230-002 | CEFTRIAXONE | EQ 500MG BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065230-003 | CEFTRIAXONE | EQ 1GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065230-004 | CEFTRIAXONE | EQ 2GM BASE/VIAL | INJECTABLE / INTRAMUSCULAR, INTRAVENOUS | 2005-08-02 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A065230-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065230-002 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065230-003 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065230-004 | AP | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A065230-001 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A065230-002 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A065230-003 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A065230-004 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A065230-001 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A065230-002 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A065230-003 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A065230-004 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A065230-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A065230-002 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A065230-003 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A065230-004 | AP | 1 | ea99ee380514… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70518-0601-0 | 2020-04-07 | C162847 | 48780-1 | 9d75b9d0-b7fa-f424-e053-dadaa90a57ce | Ceftriaxone for Injection, USP |
| 70518-0601-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b7fa-f424-e053-dadaa90a57ce | Ceftriaxone for Injection, USP |