Levocetirizine dihydrochloride
- Product NDC
- 63672-0051
- 11-digit product format
- 636720051
- Labeler code
- 63672
- Product ID
- 63672-0051_c1f4c652-5aa3-4f4f-a201-9d540a058557
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levocetirizine dihydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Synthon Pharmaceuticals, Inc.
- Application
- ANDA090229
- Marketing category
- ANDA
- Marketing start
- 2010-11-26
- Marketing end
- 0000-00-00
- Substance
- LEVOCETIRIZINE DIHYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Levocetirizine dihydrochloride | ACTIVE INGREDIENT | SOD6A38AGA | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.] | 1 | |
| Levocetirizine | ACTIVE MOIETY | 6U5EA9RT2O | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.] | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.] | 1 | |
| polyethylene glycol 400 | INACTIVE INGREDIENT | B697894SGQ | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63672-0051 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.] | 10 | Legacy NDC | 20250529_c0b39c8e-9e43-43bb-9151-b0c3c29e84fa.zip |
| 63672-0051 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.] | 1 | Legacy NDC | 20101211_2f42fc80-ae39-4301-b140-36e59d71666e.zip |