Loratadine D
- Product NDC
- 63629-4790
- 11-digit product format
- 636294790
- Labeler code
- 63629
- Product ID
- 63629-4790_db18e5df-c35f-4fca-a68c-c4dc5012513f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loratadine, Pseudoephedrine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA076050
- Marketing category
- ANDA
- Marketing start
- 2012-01-19
- Marketing end
- 0000-00-00
- Substance
- LORATADINE; PSEUDOEPHEDRINE SULFATE
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 63629-4790 | D | Discontinued by firm | 2026-09-09 | ||
| excluded package | package | 63629-4790 | 63629-4790-1 | D | Discontinued by firm | 2026-09-09 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-4790-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-4790-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-4790-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-4790-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-4790-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-4790-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63629-4790-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63629-4790-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63629-4790-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63629-4790-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63629-4790-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63629-4790-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | LORATADINE; PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A076050-001 | LORATADINE AND PSEUDOEPHEDRINE SULFATE | 5MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2003-01-30 | e64feba35796… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| allergy and nasal congestion | LORATADINE, PSEUDOEPHEDRINE SULFATE | Kroger Company | 934dda74-7995-46f1-b6f2-f4b928a2eeb2 | 2026-07-08 | Warnings | 076050 ANDA076050 |
| allergy relief d 12 | LORATADINE, PSEUDOEPHEDRINE SULFATE | Walgreen Company | 7e6ea563-cc79-4683-b600-0691e0fb78ab | 2026-04-09 | Warnings | 076050 ANDA076050 |
| allergy relief d 12 | LORATADINE, PSEUDOEPHEDRINE SULFATE | CVS Pharmacy | 0ca2b074-7137-478c-b32c-67f834f6c454 | 2026-03-15 | Warnings | 076050 ANDA076050 |
| loratadine D | LORATADINE, PSEUDOEPHEDRINE SULFATE | Sportpharm LLC | bb54f613-b2ab-48fd-83c9-2038ec7097f6 | 2026-02-06 | Warnings | 076050 ANDA076050 |
| good neighbor pharmacy loratadine d | LORATADINE, PSEUDOEPHEDRINE SULFATE | Amerisource Bergen | 90b0a155-b92c-45e3-959f-8f21065d31dd | 2025-09-12 | Warnings | 076050 ANDA076050 |
| equate allergy and congestion relief | LORATADINE, PSEUDOEPHEDRINE SULFATE | Wal-Mart Stores Inc | 306e8736-b27f-4445-b613-3e5b609f8d42 | 2025-07-17 | Warnings | 076050 ANDA076050 |
| foster and thrive allergy D 12 hour | LORATADINE, PSEUDOEPHEDRINE SULFATE | Strategic Sourcing Services LLC | 4626e3ca-d3e9-46ad-9c53-66d27c82aed7 | 2025-06-13 | Warnings | 076050 ANDA076050 |
| allergy relief d | LORATADINE, PSEUDOEPHEDRINE SULFATE | Meijer Distribution Inc | dd19215c-0da7-483a-88e3-6a32ac210c4c | 2025-05-28 | Warnings | 076050 ANDA076050 |
| loratadine D | LORATADINE, PSEUDOEPHEDRINE SULFATE | Padagis Israel Pharmaceuticals Ltd | 01e61c73-3b81-4683-b1a9-8784c0d565b1 | 2025-03-03 | Warnings | 076050 ANDA076050 |
| Allergy and Congestion Relief | LORATADINE, PSEUDOEPHEDRINE SULFATE | L. Perrigo Company | b5589371-48bc-44a5-bcab-018a92e22796 | 2024-02-26 | Warnings | 076050 ANDA076050 |
| Allergy Relief D | LORATADINE, PSEUDOEPHEDRINE SULFATE | Rite Aid Corporation | f08ebf00-a1d7-4a6f-a84f-195d000de53d | 2024-02-16 | Warnings | 076050 ANDA076050 |
| kirkland signature allerclear d 12 hr | LORATADINE, PSEUDOEPHEDRINE SULFATE | Costco Wholesale Company | 1534720b-f8f8-4db5-99e0-cfa49acf9299 | 2023-07-07 | Warnings | 076050 ANDA076050 |
| topcare allergy and congestion relief | LORATADINE, PSEUDOEPHEDRINE SULFATE | Topco Associates LLC | dd93d172-2a3a-4e4c-a237-7668acbd537d | 2022-02-16 | Warnings | 076050 ANDA076050 |
| Alavert Allergy and Congestion D-12 hour | LORATADINE AND PSEUDOEPHEDRINE SULFATE | Foundation Consumer Brands | 1a669f3c-36a6-439e-843d-47638fa217e8 | 2021-12-07 | Warnings | 076050 ANDA076050 |
| perrigo allergy d | LORATADINE, PSEUDOEPHEDRINE SULFATE | L. Perrigo Company | 955c9f49-38af-4b48-b325-60fa94bfe60b | 2021-10-08 | Warnings | 076050 ANDA076050 |
| Leader Allergy Relief D12 | LORATADINE, PSEUDOEPHEDRINE SULFATE | Cardinal Health 110, LLC. dba Leader | 98bd6186-2bd2-4f46-99df-f509bb00e03a | 2021-06-17 | Warnings | 076050 ANDA076050 |
| signature care allergy and congestion relief | LORATADINE, PSEUDOEPHEDRINE SULFATE | Safeway | e1993d05-248e-48da-838c-068f8263c2eb | 2021-03-08 | Warnings | 076050 ANDA076050 |
| allergy relief d | LORATADINE, PSEUDOEPHEDRINE SULFATE | Publix Super Markets Inc | 8209d7d5-4ecc-4170-ba50-5917bd8c46d4 | 2020-10-19 | Warnings | 076050 ANDA076050 |