Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Product NDC
- 47335-724
- 11-digit product format
- 473350724
- Labeler code
- 47335
- Product ID
- 47335-724_554fd38b-a6cf-4b55-bfb2-ee7cb3ef48e8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090818
- Marketing category
- ANDA
- Marketing start
- 2018-03-01
- Substance
- FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 60; 120 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090818-001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2015-01-29 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FEXOFENADINE HYDROCHLORIDE | 60 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2S068B75ZU | Internal UNII lookup |
| 6V9V2RYJ8N | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 997406 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8afc0167-17bf-4ccd-91c9-8fb9c4e241c1 | Available on FDA.report |
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47335-724-60 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 5 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 5 | 13 | |
| 47335-724-64 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 6 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 6 | 13 | |
| 47335-724-66 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 2 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 2 | 13 | |
| 47335-724-75 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 4 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 4 | 13 | |
| 47335-724-83 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | 13 | |
| 47335-724-94 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | 13 | |
| 47335-724-94 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | 13 | |
| 47335-724-95 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 3 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 3 | 13 | |
| 47335-724-95 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | 13 | |
| 47335-724-99 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 2 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 2 | 13 | |
| 47335-724-99 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 47335-724 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 13 | Current NDC, Legacy NDC, 11 package rows | 20250312_8afc0167-17bf-4ccd-91c9-8fb9c4e241c1.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 997406 | fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet | PSN | 8afc0167-17bf-4ccd-91c9-8fb9c4e241c1 | 13 |
| 997406 | 12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet | SCD | 8afc0167-17bf-4ccd-91c9-8fb9c4e241c1 | 13 |
| 997406 | fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet | SY | 8afc0167-17bf-4ccd-91c9-8fb9c4e241c1 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 47335-724-60 | 47335072460 | 5 in 1 BLISTER PACK | Historical | |||||
| 47335-724-64 | 47335072464 | 6 BLISTER PACK in 1 CARTON (47335-724-64) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60) | 6 blister pack | 2018-03-01 | 0000-00-00 | No | No | Current |
| 47335-724-66 | 47335072466 | 2 BLISTER PACK in 1 CARTON (47335-724-66) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60) | 2 blister pack | 2018-03-01 | 0000-00-00 | No | No | Current |
| 47335-724-75 | 47335072475 | 4 BLISTER PACK in 1 CARTON (47335-724-75) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60) | 4 blister pack | 2018-03-01 | 0000-00-00 | No | No | Current |
| 47335-724-83 | 47335072483 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-724-83) | 2018-03-01 | 0000-00-00 | No | No | Current | |
| 47335-724-94 | 47335072494 | 1 BLISTER PACK in 1 CARTON (47335-724-94) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2018-03-01 | 0000-00-00 | No | No | Current |
| 47335-724-95 | 47335072495 | 3 BLISTER PACK in 1 CARTON (47335-724-95) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 3 blister pack | 2018-03-01 | 0000-00-00 | No | No | Current |
| 47335-724-99 | 47335072499 | 2 BLISTER PACK in 1 CARTON (47335-724-99) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2018-03-01 | 0000-00-00 | No | No | Current |