Pilocarpine Hydrochloride
- Product NDC
- 0527-1313
- 11-digit product format
- 005271313
- Labeler code
- 0527
- Product ID
- 0527-1313_3062d101-0b98-4101-8f53-13ae694873fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pilocarpine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA077220
- Marketing category
- ANDA
- Marketing start
- 2005-10-14
- Substance
- PILOCARPINE HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pilocarpine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PILOCARPINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0WW6D218XJ |
| Rxcui | 1000913, 1001004 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0527-1313-01 | Pilocarpine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PILOCARPINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0WW6D218XJ | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 11 | |
| PILOCARPINE | ACTIVE MOIETY | 01MI4Q9DI3 | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 11 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 11 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 11 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 11 | |
| INDIGOTINDISULFONATE SODIUM | INACTIVE INGREDIENT | D3741U8K7L | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 11 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 11 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 11 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 11 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 11 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 11 | |
| PILOCARPINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0WW6D218XJ | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PILOCARPINE | ACTIVE MOIETY | 01MI4Q9DI3 | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-1313 | PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 18 | Current NDC, Legacy NDC, 1 package rows | 20241109_8db0db4f-55ad-46b2-af50-e71b4a763aaa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0527-1313-01 | 00527131301 | 100 TABLET, FILM COATED in 1 BOTTLE (0527-1313-01) | 2005-10-14 | 0000-00-00 | No | No | Current |