21 C.F.R. § 522.90a
Ampicillin trihydrate suspension.
Cite as 21 C.F.R. § 522.90a (2026)
(a)
Specifications.
(1) Each milliliter contains ampicillin trihydrate equivalent to 200 milligrams (mg) of ampicillin.
(2) Each milliliter contains ampicillin trihydrate equivalent to 150 mg of ampicillin.
(b)
Sponsors.
See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 054771 for use of product described in paragraph (a)(1) as in paragraphs (d)(1), (d)(2), (d)(3)(i)(A), (d)(3)(ii)(A), (d)(3)(iii), and (d)(4) of this section.
(2) No. 054771 for use of product described in paragraph (a)(2) as in paragraphs (d)(3)(i)(B), (d)(3)(ii)(B), and (d)(3)(iii) of this section.
(c)
Related tolerances.
See § 556.40 of this chapter.
(d)
Conditions of use
—(1)
Cattle
—(i)
Amount.
For enteritis: 3 mg per pound of body weight, intramuscularly, once or twice daily, for up to 3 days. For pneumonia: 3 mg per pound of body weight, intramuscularly, twice daily, for up to 3 days.
(ii)
Indications for use.
For treatment of bacterial enteritis in calves caused by
Escherichia coli
and bacterial pneumonia caused by
Pasteurella
spp. susceptible to ampicillin.
(iii)
Limitations.
Treated animals must not be slaughtered for food use during treatment or for 9 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2)
Swine
—(i)
Amount.
3 mg per pound of body weight by intramuscular injection, once or twice daily, for up to 3 days.
(ii)
Indications for use.
Treatment of bacterial enteritis (colibacillosis) caused by
E. coli
and bacterial pneumonia caused by
Pasteurella
spp. susceptible to ampicillin.
(iii)
Limitations.
Treated animals must not be slaughtered for food use during treatment or for 15 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3)
Dogs
—(i)
Amount.
(A) 3 to 6 mg per pound of body weight by intramuscular injection, once or twice daily. Usual treatment is 3 to 5 days.
(B) 3 to 5 mg of ampicillin per pound of body weight, once a day for up to 4 days.
(ii)
Indications for use.
(A) Treatment of respiratory tract infections due to
E. coli, Pseudomonas
spp.,
Proteus
spp.,
Staphylococcus
spp., and
Streptococcus
spp.; tonsillitis due to
E. coli, Pseudomonas
spp.,
Streptococcus
spp., and
Staphylococcus
spp.; generalized infections (septicemia) associated with abscesses, lacerations, and wounds due to
Staphylococcus
spp. and
Streptococcus
spp.
(B) Treatment of bacterial infections of the upper respiratory tract (tonsillitis) due to
Streptococcus
spp.,
Staphylococcus
spp.,
E. coli, Proteus
spp., and
Pasteurella
spp., and soft tissue infections (abscesses, lacerations, and wounds) due to
Staphylococcus
spp.,
Streptococcus
spp., and
E. coli,
when caused by susceptible organisms.
(iii)
Limitations.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(4)
Cats
—(i)
Amount.
5 to 10 mg per pound of body weight by intramuscular or subcutaneous injection, once or twice daily. Usual treatment is 3 to 5 days.
(ii)
Indications for use.
Treatment of generalized infections (septicemia) associated with abscesses, lacerations, and wounds due to
Staphylococcus
spp.,
Streptococcus
spp., and
Pasteurella
spp.
(iii)
Limitations.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[79 FR 16183, Mar. 25, 2014]
- Cross-references to the CFR
- 510.600556.40