- Product NDC
- 50090-1944
- 11-digit product format
- 500901944
- Labeler code
- 50090
- Product ID
- 50090-1944_e7d82789-54b1-4a5b-b9bf-982616a93ec6
- Type
- VACCINE
- Nonproprietary name
- pneumococcal 13-valent conjugate vaccine
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- A-S Medication Solutions
- Application
- BLA125324
- Marketing category
- BLA
- Marketing start
- 2010-03-12
- Substance
- STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
- Active strength
- 2.2; 2.2; 2.2; 2.2; 2.2; 4.4; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
- Pharmacologic classes
- Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Vaccines, Conjugate [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 50090-1944-0 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 50090-1944-0 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 50090-1944-0 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 50090-1944-0 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 50090-1944-0 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 50090-1944-0 | 9bebd1f3094a… | 5416666fcb17… |