Apraclonidine Ophthalmic
- Product NDC
- 17478-716
- 11-digit product format
- 174780716
- Labeler code
- 17478
- Product ID
- 17478-716_8550ca6e-db0b-463a-a2fe-1cd0360cf734
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Apraclonidine Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA077764
- Marketing category
- ANDA
- Marketing start
- 2009-08-12
- Marketing end
- 0000-00-00
- Substance
- APRACLONIDINE HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 02c8f418-c0c9-b236-9f18-ee3885c38acd | Product name | 1 | 20140508 |
| ba85cd0d-986e-2249-069d-4a15a4d0199f | Product name | 1 | 20140508 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17478-716-10 | 2024-01-30 | C162847 | 48780-1 | 1030e365-617f-111a-e063-dadaa90a10e2 | Apraclonidine Ophthalmic Solution, USP 0.5% as base |
| 17478-716-11 | 2024-01-30 | C162847 | 48780-1 | 1030e365-617f-111a-e063-dadaa90a10e2 | Apraclonidine Ophthalmic Solution, USP 0.5% as base |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17478-716-10 | Apraclonidine Ophthalmic | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 12 | |
| 17478-716-10 | Apraclonidine Ophthalmic | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 12 | |
| 17478-716-11 | Apraclonidine Ophthalmic | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 12 | |
| 17478-716-11 | Apraclonidine Ophthalmic | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17478-716-10 | ML - Milliliter | 17478-716 | bda8e5f5-084f-407e-8a35-a48b9f282edb | 1 | 2012-07-24 |
| 17478-716-11 | ML - Milliliter | 17478-716 | 5575e8ad-8cf0-4ccf-a9e7-7948eaa40b32 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| apraclonidine hydrochloride | ACTIVE INGREDIENT | D2VW67N38H | APRACLONIDINE OPHTHALMIC (APRACLONIDINE HYDROCHLORIDE) SOLUTION/ DROPS [AKORN INC.] | 4 | |
| apraclonidine | ACTIVE MOIETY | 843CEN85DI | APRACLONIDINE OPHTHALMIC (APRACLONIDINE HYDROCHLORIDE) SOLUTION/ DROPS [AKORN INC.] | 4 | |
| benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | APRACLONIDINE OPHTHALMIC (APRACLONIDINE HYDROCHLORIDE) SOLUTION/ DROPS [AKORN INC.] | 4 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | APRACLONIDINE OPHTHALMIC (APRACLONIDINE HYDROCHLORIDE) SOLUTION/ DROPS [AKORN INC.] | 4 | |
| sodium acetate | INACTIVE INGREDIENT | 4550K0SC9B | APRACLONIDINE OPHTHALMIC (APRACLONIDINE HYDROCHLORIDE) SOLUTION/ DROPS [AKORN INC.] | 4 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | APRACLONIDINE OPHTHALMIC (APRACLONIDINE HYDROCHLORIDE) SOLUTION/ DROPS [AKORN INC.] | 4 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | APRACLONIDINE OPHTHALMIC (APRACLONIDINE HYDROCHLORIDE) SOLUTION/ DROPS [AKORN INC.] | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308345 | apraclonidine HCl 0.5 % Ophthalmic Solution | PSN | dc7d3a9f-c0b9-411c-9c62-0a14f1718b00 | 12 |
| 308345 | apraclonidine 5 MG/ML Ophthalmic Solution | SCD | dc7d3a9f-c0b9-411c-9c62-0a14f1718b00 | 12 |
| 308345 | apraclonidine 0.5 % Ophthalmic Solution | SY | dc7d3a9f-c0b9-411c-9c62-0a14f1718b00 | 12 |
| 308345 | apraclonidine 5 MG/ML (apraclonidine hydrochloride 5.75 MG/ML) Ophthalmic Solution | SY | dc7d3a9f-c0b9-411c-9c62-0a14f1718b00 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 17478-716-10 | 17478071610 | 1 BOTTLE, DROPPER in 1 CARTON (17478-716-10) > 5 mL in 1 BOTTLE, DROPPER | 2009-08-12 | 0000-00-00 | No | No | Current |
| 17478-716-11 | 17478071611 | 1 BOTTLE, DROPPER in 1 CARTON (17478-716-11) > 10 mL in 1 BOTTLE, DROPPER | 2009-08-12 | 0000-00-00 | No | No | Current |