Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
- Product NDC
- 63187-955
- 11-digit product format
- 631870955
- Labeler code
- 63187
- Product ID
- 63187-955_0a08231c-188b-4c9a-8680-d43152d71983
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine HCl, Pseudoephedrine HCl
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077170
- Marketing category
- ANDA
- Marketing start
- 2008-04-10
- Marketing end
- 0000-00-00
- Substance
- CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 5 mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-955 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HCL, PSEUDOEPHEDRINE HCL) TABLET, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | Legacy NDC | 20210112_5d91286c-5650-462f-bd3d-f3b2387afcde.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-955-12 | 63187095512 | 12 BLISTER PACK in 1 CARTON (63187-955-12) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 12 blister pack | 2018-01-01 | 0000-00-00 | No | No | Current |
| 63187-955-24 | 63187095524 | 24 BLISTER PACK in 1 CARTON (63187-955-24) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 24 blister pack | 2018-01-01 | 0000-00-00 | No | No | Current |