Orange Book product · Brand (NDA)
SODIUM BICARBONATE IN PLASTIC CONTAINER
SODIUM BICARBONATE
At a glance
Jun 03, 1986
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 03, 1986
40 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
SODIUM BICARBONATE
Strength
44.6MEQ/50ML (0.9MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 019443
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2026SODIUM BICARBONATEGeneric (ANDA)
ANDA 220788 · ASPIRO
- 2026SODIUM BICARBONATEGeneric (ANDA)
ANDA 217523 · AMNEAL
- 2025SODIUM BICARBONATEGeneric (ANDA)
ANDA 206688 · FRESENIUS KABI USA
- 2025SODIUM BICARBONATEGeneric (ANDA)
ANDA 219701 · ANTHEA PHARMA
- 2024SODIUM BICARBONATEGeneric (ANDA)
ANDA 216042 · LONG GROVE PHARMS
- 2023SODIUM BICARBONATEGeneric (ANDA)
ANDA 217594 · STERISCIENCE
- 2023SODIUM BICARBONATEGeneric (ANDA)
ANDA 216364 · OMNIVIUM PHARMS
- 2019SODIUM BICARBONATEGeneric (ANDA)
ANDA 211091 · EXELA PHARMA
- 2017SODIUM BICARBONATEGeneric (ANDA)
ANDA 202432 · HOSPIRA
- 2017SODIUM BICARBONATEGeneric (ANDA)
ANDA 203449 · INTL MEDICATION SYS
- 2017SODIUM BICARBONATEGeneric (ANDA)
ANDA 202679 · HOSPIRA
- 2017SODIUM BICARBONATEGeneric (ANDA)
ANDA 202495 · HOSPIRA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

