imipramine hydrochloride
Generic: imipramine hydrochloride
Labeler: lupin pharmaceuticals, inc.Drug Facts
Product Profile
Brand Name
imipramine hydrochloride
Generic Name
imipramine hydrochloride
Labeler
lupin pharmaceuticals, inc.
Dosage Form
TABLET, FILM COATED
Routes
Active Ingredients
imipramine hydrochloride 50 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
68180-313
Product ID
68180-313_b891d3a3-3346-441e-99cc-03528b4afa46
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA090441
Listing Expiration
2026-12-31
Marketing Start
2010-12-21
Pharmacologic Class
Classes
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
68180313
Hyphenated Format
68180-313
Supplemental Identifiers
RxCUI
UNII
Packaging Origin
Original Packager
Resolved Product View
Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.
Resolved Identity
Brand Name
imipramine hydrochloride (source: ndc)
Generic Name
imipramine hydrochloride (source: ndc)
Application Number
ANDA090441 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 50 mg/1
Packaging
- HOW SUPPLIED Imipramine hydrochloride tablets USP, containing 10 mg imipramine hydrochloride, are round, biconvex, yellow film-coated tablets debossed with "LU" on one side and "V11" on the other side. They are supplied as follows: NDC 68180-311-01 Bottles of 100's NDC 68180-311-02 Bottles of 500's Imipramine hydrochloride tablets USP, containing 25 mg imipramine hydrochloride, are round, biconvex, green film-coated tablets debossed with "LU" on one side and "V12" on the other side. They are supplied as follows: NDC 68180-312-01 Bottles of 100's NDC 68180-312-02 Bottles of 500's Imipramine hydrochloride tablets USP, containing 50 mg imipramine hydrochloride, are round, biconvex, reddish brown film-coated tablets debossed with "LU" on one side and "V13" on the other side. They are supplied as follows: NDC 68180-313-01 Bottles of 100's NDC 68180-313-02 Bottles of 500's Store at 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed containers. Dispense in tight container (USP) with a child-resistant closure. ANIMAL PHARMACOLOGY & TOXICOLOGY A. Acute: Oral LD 50 ranges are as follows: Rat 355 to 682 mg/kg Dog 100 to 215 mg/kg Depending on the dosage in both species, toxic signs proceeded progressively from depression, irregular respiration and ataxia to convulsions and death. B. Reproduction/Teratogenic: The overall evaluation may be summed up in the following manner: Oral: Independent studies in three species (rat, mouse, and rabbit) revealed that when imipramine hydrochloride is administered orally in doses up to approximately 2-1/2 times the maximum human dose in the first 2 species and up to 25 times the maximum human dose in the third species, the drug is essentially free from teratogenic potential. In the three species studied, only one instance of fetal abnormality occurred (in the rabbit) and in that study there was likewise an abnormality in the control group. However, evidence does exist from the rat studies that some systemic and embryotoxic potential is demonstrable. This is manifested by reduced litter size, a slight increase in the stillborn rate, and a reduction in the mean birth weight.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Imipramine Hydrochloride Tablets 10 mg – Bottle of 100s NDC 68180-311-01 bottles of 100s Imipramine Hydrochloride Tablets 25 mg – Bottle of 100s NDC 68180-312-01 bottles of 100s Imipramine Hydrochloride Tablets 50 mg – Bottle of 100s NDC 68180-313-01 bottles of 100s imi-10-100 imi-25-100 imi-50-100
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
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