OLOPATADINE HYDROCHLORIDE
- Product NDC
- 70069-007
- 11-digit product format
- 700690007
- Labeler code
- 70069
- Product ID
- 70069-007_a2432c67-2a64-4710-90c7-abd0c5a188af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OLOPATADINE HYDROCHLORIDE
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Somerset Therapeutics, LLC
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70069-007-01 | ML - Milliliter | 70069-007 | 26953609-7a4a-4433-ada9-f7fc46d52a1c | 1 | 2016-12-07 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1111339 | olopatadine HCl 0.1 % Ophthalmic Solution | PSN | 994ca5d1-2dd5-4abd-a169-5379efa2a538 | 11 |
| 1111339 | olopatadine 1 MG/ML Ophthalmic Solution | SCD | 994ca5d1-2dd5-4abd-a169-5379efa2a538 | 11 |
| 1111339 | olopatadine 0.1 % Ophthalmic Solution | SY | 994ca5d1-2dd5-4abd-a169-5379efa2a538 | 11 |
| 1111339 | olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic Solution | SY | 994ca5d1-2dd5-4abd-a169-5379efa2a538 | 11 |
| 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 |
|---|---|---|---|---|---|---|---|---|
| 70069-007-01 | 70069000701 | 1 BOTTLE in 1 CARTON (70069-007-01) > 5 mL in 1 BOTTLE | 1 bottle | 2015-12-07 | 0000-00-00 | No | No | Current |