FDA Orange Book · active-ingredient family
Sodium bicarbonate
Sodium bicarbonate: 1 brand, 16 generics; first approved Jun 03, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
16
Listed patents
0
Presentations
26
Brand (NDA) products
Originator applications
- ABBOTTNDA 01944319862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 44.6MEQ/50ML (0.9MEQ/ML) SOLUTION INTRAVENOUS Discontinued — 50MEQ/50ML (1MEQ/ML) SOLUTION INTRAVENOUS Discontinued —
Generic (ANDA) products (16)
Abbreviated applications
- SODIUM BICARBONATEMILLA PHARMSANDA 2190892026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MEQ/50ML (1MEQ/ML) SOLUTION INTRAVENOUS Rx AP - SODIUM BICARBONATEASPIROANDA 22078820263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MEQ/10ML (0.5MEQ/ML) SOLUTION INTRAVENOUS Rx AP 10MEQ/10ML (1MEQ/ML) SOLUTION INTRAVENOUS Rx AP 50MEQ/50ML (1MEQ/ML) SOLUTION INTRAVENOUS Rx AP - SODIUM BICARBONATEAMNEALANDA 2175232026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MEQ/50ML (1MEQ/ML) SOLUTION INTRAVENOUS Rx AP - SODIUM BICARBONATEFRESENIUS KABI USAANDA 20668820252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MEQ/5ML (0.5MEQ/ML) SOLUTION INTRAVENOUS Rx AP 50MEQ/50ML (1MEQ/ML) SOLUTION INTRAVENOUS Rx AP - SODIUM BICARBONATEANTHEA PHARMAANDA 2197012025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MEQ/50ML (1MEQ/ML) SOLUTION INTRAVENOUS Rx AP - SODIUM BICARBONATELONG GROVE PHARMSANDA 2160422024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MEQ/50ML (1MEQ/ML) SOLUTION INTRAVENOUS Rx AP - SODIUM BICARBONATESTERISCIENCEANDA 2175942023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MEQ/50ML (1MEQ/ML) SOLUTION INTRAVENOUS Rx AP - SODIUM BICARBONATEOMNIVIUM PHARMSANDA 2163642023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MEQ/50ML (1MEQ/ML) SOLUTION INTRAVENOUS Rx AP - SODIUM BICARBONATERSEXELA PHARMAANDA 21109120194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MEQ/10ML (0.5MEQ/ML) SOLUTION INTRAVENOUS Rx AP 44.6MEQ/50ML (0.9MEQ/ML) SOLUTION INTRAVENOUS Rx AP 10MEQ/10ML (1MEQ/ML) SOLUTION INTRAVENOUS Rx AP 50MEQ/50ML (1MEQ/ML) SOLUTION INTRAVENOUS Rx AP - SODIUM BICARBONATEHOSPIRAANDA 2024322017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MEQ/50ML (1MEQ/ML) SOLUTION INTRAVENOUS Rx AP - SODIUM BICARBONATEINTL MEDICATION SYSANDA 2034492017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MEQ/50ML (1MEQ/ML) SOLUTION INTRAVENOUS Rx AP - SODIUM BICARBONATEHOSPIRAANDA 2026792017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MEQ/10ML (0.5MEQ/ML) SOLUTION INTRAVENOUS Rx AP - SODIUM BICARBONATEHOSPIRAANDA 2024952017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MEQ/10ML (1MEQ/ML) SOLUTION INTRAVENOUS Rx AP - SODIUM BICARBONATEHOSPIRAANDA 20249420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 44.6MEQ/50ML (0.9MEQ/ML) SOLUTION INTRAVENOUS Rx AP 50MEQ/50ML (1MEQ/ML) SOLUTION INTRAVENOUS Rx AP - SODIUM BICARBONATERSHOSPIRAANDA 2029812016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MEQ/5ML (0.5MEQ/ML) SOLUTION INTRAVENOUS Rx AP - SODIUM BICARBONATEHOSPIRAANDA 07739420052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 44.6MEQ/50ML (0.9MEQ/ML) SOLUTION INTRAVENOUS Discontinued — 50MEQ/50ML (1MEQ/ML) SOLUTION INTRAVENOUS Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
40 yr 9 mo ago
Most recent approval
27 d ago
Approvals span 1986–2026 across 17 FDA applications.
Brand (NDA) 16%
Generic (ANDA) 1694%
Sodium bicarbonate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
