Pilocarpine Hydrochloride
- Product NDC
- 17478-224
- 11-digit product format
- 174780224
- Labeler code
- 17478
- Product ID
- 17478-224_7353e797-47bb-45a4-8cbd-d99b357a4ea1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pilocarpine Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA204398
- Marketing category
- ANDA
- Marketing start
- 2017-09-28
- Marketing end
- 0000-00-00
- Substance
- PILOCARPINE HYDROCHLORIDE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor 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 |
|---|---|---|---|
| 92fc48b4-3815-4611-a8be-f74b29f9b350 | Product name | 2 | 20260130 |
| c8f45a17-34ae-46eb-871b-470615085910 | Product name | 1 | 20250630 |
| dad00d81-2cbe-bbab-dd06-a12043b5e56d | Product name | 4 | 20210512 |
| 419b812f-d1a6-2de2-5dee-bec68d6ec699 | Product name | 2 | 20200123 |
| 38c480e0-b6d3-b416-6514-a787406e5176 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17478-224-12 | 2024-01-30 | C162847 | 48780-1 | 1030e365-537f-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION. PILOCARPINE HYDROCHLORIDE Ophthalmic Solution, USP 1%, 2% and 4% Initial U.S. Approval: 1974 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17478-224-12 | Pilocarpine Hydrochloride | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | 7 | |
| 17478-224-12 | Pilocarpine Hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17478-224-12 | ML - Milliliter | 17478-224 | 0533f1ec-cb0c-4b7b-8043-405b1a81e588 | 1 | 2012-07-24 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1000647 | pilocarpine HCl 1 % Ophthalmic Solution | PSN | fa03947c-6844-45df-aa22-b584c5681269 | 7 |
| 1000862 | pilocarpine HCl 2 % Ophthalmic Solution | PSN | fa03947c-6844-45df-aa22-b584c5681269 | 7 |
| 1000897 | pilocarpine HCl 4 % Ophthalmic Solution | PSN | fa03947c-6844-45df-aa22-b584c5681269 | 7 |
| 1000647 | pilocarpine hydrochloride 10 MG/ML Ophthalmic Solution | SCD | fa03947c-6844-45df-aa22-b584c5681269 | 7 |
| 1000862 | pilocarpine hydrochloride 20 MG/ML Ophthalmic Solution | SCD | fa03947c-6844-45df-aa22-b584c5681269 | 7 |
| 1000897 | pilocarpine hydrochloride 40 MG/ML Ophthalmic Solution | SCD | fa03947c-6844-45df-aa22-b584c5681269 | 7 |
| 1000647 | pilocarpine hydrochloride 1 % Ophthalmic Solution | SY | fa03947c-6844-45df-aa22-b584c5681269 | 7 |
| 1000862 | pilocarpine hydrochloride 2 % Ophthalmic Solution | SY | fa03947c-6844-45df-aa22-b584c5681269 | 7 |
| 1000897 | pilocarpine hydrochloride 4 % Ophthalmic Solution | SY | fa03947c-6844-45df-aa22-b584c5681269 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 17478-224-12 | 17478022412 | 1 BOTTLE, DROPPER in 1 CARTON (17478-224-12) > 15 mL in 1 BOTTLE, DROPPER | 2017-09-28 | 0000-00-00 | No | No | Current |