nasal decongestant
- Product NDC
- 56062-054
- 11-digit product format
- 560620054
- Labeler code
- 56062
- Product ID
- 56062-054_2f33e318-a124-4f15-a42e-c3cab5b0b185
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Publix Super Markets Inc
- Application
- ANDA075153
- Marketing category
- ANDA
- Marketing start
- 2000-03-20
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 120 mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- nasal decongestant
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6V9V2RYJ8N |
| Rxcui | 1049154 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 56062-054-60 | nasal decongestant | 20 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 20 | | 3 |
| 56062-054-60 | nasal decongestant | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PUBLIX SUPER MARKETS INC] | 1 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PUBLIX SUPER MARKETS INC] | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PUBLIX SUPER MARKETS INC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PUBLIX SUPER MARKETS INC] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PUBLIX SUPER MARKETS INC] | 1 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PUBLIX SUPER MARKETS INC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PUBLIX SUPER MARKETS INC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PUBLIX SUPER MARKETS INC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PUBLIX SUPER MARKETS INC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PUBLIX SUPER MARKETS INC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PUBLIX SUPER MARKETS INC] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 56062-054-60 | 56062005460 | 20 BLISTER PACK in 1 CARTON (56062-054-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 20 blister pack | 2000-03-20 | No | No | Current |