INFANRIX
- Product NDC
- 50090-2883
- Requested package NDC
- 50090-2883-0
- 11-digit product format
- 500902883
- Labeler code
- 50090
- Product ID
- 50090-2883_4b64831f-ea62-443d-acb9-7096f143b998
- Type
- VACCINE
- Nonproprietary name
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
- Dosage form
- SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- A-S Medication Solutions
- Application
- BLA103647
- Marketing category
- BLA
- Marketing start
- 2009-07-24
- Marketing end
- 0000-00-00
- Substance
- CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)
- Active strength
- 10 [iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
- Pharmacologic classes
- Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Tetanus Toxoid [CS],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Diphtheria Toxoid [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [CS],Vaccines, Inactivated [CS],Pertussis Vaccine [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pertussis Vaccine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | 2026-08-03 |
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-2883 | 50090-2883-0 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-2883-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-b4a8-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use INFANRIX safely and effectively. See full prescribing information for INFANRIX. INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) Suspension for Intramuscular Injection Initial U.S. Approval: 1997 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 103647 | Infanrix | Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed | 351(a) | Rx | 2026-06-01 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-2883-0 | 50090288300 | 10 SYRINGE in 1 CARTON (50090-2883-0) > .5 mL in 1 SYRINGE (50090-2883-9) | 10 syringe | 2009-07-24 | 0000-00-00 | No | No | Current |