OLOPATADINE HYDROCHLORIDE
- Product NDC
- 53002-0510
- 11-digit product format
- 530020510
- Labeler code
- 53002
- Product ID
- 53002-0510_a74d1800-2b21-4d30-bda3-afa71291eb28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OLOPATADINE HYDROCHLORIDE
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA206306
- Marketing category
- ANDA
- Marketing start
- 2015-12-07
- Marketing end
- 0000-00-00
- Substance
- OLOPATADINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 | 53002-0510 | I | Inactivated by FDA | 2026-08-07 | ||
| excluded package | package | 53002-0510 | 53002-0510-1 | I | Inactivated by FDA | 2026-08-07 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53002-0510-1 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53002-0510-1 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53002-0510-1 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53002-0510-1 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53002-0510-1 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53002-0510-1 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53002-0510-1 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53002-0510-1 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53002-0510-1 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206306-001 | OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 |
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 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2015-12-07 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2015-12-07 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2015-12-07 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2015-12-07 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2015-12-07 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | AT | 2015-12-07 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A206306-001 | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS / OPHTHALMIC | 2015-12-07 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A206306-001 | AT | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206306-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A206306-001 | AT | 1 | 5aa47cf7b7d7… |
| 2019-12-14 00:12 UTC | 2019-12 | A206306-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A206306-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A206306-001 | AT | 1 | ea99ee380514… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 624001e0-0eba-4aac-a60c-c2ecb37d4f08 | Product name | 1 | 20220927 |
| abab02bf-82c6-4b6c-8cb4-2ee39055aeb1 | Product name | 3 | 20210312 |
| ee1438f7-d464-b7de-1b3a-aae378f7d672 | Product name | 8 | 20200121 |
| 4101b788-a943-3f81-6947-4acf7be2af4d | Product name | 4 | 20190703 |
| ca2d4a1a-2b5b-4256-9aad-735e9282b3ee | Product name | 1 | 20150323 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53002-0510-1 | 2025-01-30 | C162847 | 48780-1 | f386c649-c974-0266-e053-dadaa90a7c1a | OLOPATADINE Hydrochloride Ophthalmic Solution USP, 0.1% Somerset Therapeutics, LLC |
| 53002-0510-1 | 2023-06-07 | C162847 | 48780-1 | f386c649-c974-0266-e053-dadaa90a7c1a | OLOPATADINE Hydrochloride Ophthalmic Solution USP, 0.1% Somerset Therapeutics, LLC |
| 53002-0510-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-c974-0266-e053-dadaa90a7c1a | OLOPATADINE Hydrochloride Ophthalmic Solution USP, 0.1% Somerset Therapeutics, LLC |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-0510-1 | OLOPATADINE HYDROCHLORIDE | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-0510 | OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 1 package rows | 20230609_c8c44b45-b69b-4ba9-bc4f-ce43e260a4b6.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Olopatadine | OLOPATADINE | A-S Medication Solutions | ef573cb9-7829-4bcb-9e4c-b26014cd94db | 2026-05-08 | Warnings | 206306 ANDA206306 |
| Olopatadine | OLOPATADINE | Somerset Therapeutics, LLC | 55142e80-c5db-46a5-85a5-e8a040bcc8cf | 2024-03-25 | Warnings | 206306 ANDA206306 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1111339 | olopatadine HCl 0.1 % Ophthalmic Solution | PSN | c8c44b45-b69b-4ba9-bc4f-ce43e260a4b6 | 3 |
| 1111339 | olopatadine 1 MG/ML Ophthalmic Solution | SCD | c8c44b45-b69b-4ba9-bc4f-ce43e260a4b6 | 3 |
| 1111339 | olopatadine 0.1 % Ophthalmic Solution | SY | c8c44b45-b69b-4ba9-bc4f-ce43e260a4b6 | 3 |
| 1111339 | olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic Solution | SY | c8c44b45-b69b-4ba9-bc4f-ce43e260a4b6 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-0510-1 | 53002051001 | 5 mL in 1 BOTTLE, DROPPER (53002-0510-1) | 5 ml | 2019-06-01 | 0000-00-00 | No | No | Current |