SUDAFED 12 HOUR
- Product NDC
- 50580-342
- 11-digit product format
- 505800342
- Labeler code
- 50580
- Product ID
- 50580-342_056dd304-133c-4e19-ae29-05de311b0077
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Application
- ANDA075153
- Marketing category
- ANDA
- Marketing start
- 2017-09-01
- Marketing end
- 0000-00-00
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 120 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-342-01 | EA - Each | 50580-342 | ad6e4fca-7de8-456f-b165-edf5b25ed3f6 | 1 | 2018-08-13 |
| 50580-342-02 | EA - Each | 50580-342 | 58f3db07-cf6f-4165-b56c-5ed28b034ab9 | 1 | 2018-03-08 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049154 | pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet | PSN | da2934cf-4940-4bea-905e-77938be9460d | 7 |
| 1049668 | SUDAFED 120 MG 12HR Extended Release Oral Tablet | PSN | da2934cf-4940-4bea-905e-77938be9460d | 7 |
| 1049668 | 12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Sudafed] | SBD | da2934cf-4940-4bea-905e-77938be9460d | 7 |
| 1049154 | 12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet | SCD | da2934cf-4940-4bea-905e-77938be9460d | 7 |
| 1049668 | 12 HR Sudafed 120 MG Extended Release Oral Tablet | SY | da2934cf-4940-4bea-905e-77938be9460d | 7 |
| 1049154 | pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet | SY | da2934cf-4940-4bea-905e-77938be9460d | 7 |
| 1049668 | Sudafed 120 MG 12 HR Extended Release Oral Tablet | SY | da2934cf-4940-4bea-905e-77938be9460d | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-342-01 | 50580034201 | 1 BLISTER PACK in 1 CARTON (50580-342-01) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2017-09-01 | 0000-00-00 | No | No | Current |
| 50580-342-02 | 50580034202 | 2 BLISTER PACK in 1 CARTON (50580-342-02) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2017-09-01 | 0000-00-00 | No | No | Current |