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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077220-001 | PILOCARPINE HYDROCHLORIDE | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | |
| A077220-002 | PILOCARPINE HYDROCHLORIDE | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077220-001 | AB |
| A077220-002 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077220-001 | PILOCARPINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2005-10-14 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077220-002 | PILOCARPINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2009-05-06 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077220-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077220-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077220-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077220-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077220-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077220-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077220-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077220-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077220-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077220-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077220-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077220-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077220-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077220-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077220-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077220-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077220-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077220-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077220-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077220-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077220-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077220-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077220-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077220-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077220-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077220-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077220-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077220-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077220-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077220-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077220-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077220-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077220-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077220-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077220-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077220-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077220-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077220-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077220-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077220-002 | AB | 1 | bb7c543d1eb4… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pilocarpine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PILOCARPINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0WW6D218XJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8db0db4f-55ad-46b2-af50-e71b4a763aaa | Available on FDA.report |
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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 351abe41-466c-4dd8-840a-0fdb68318bd5 | Product name | 1 | 20230316 |
| 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 |
|---|---|---|---|---|---|
| 0527-1313-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3903-111a-e063-dadaa90a10e2 | Pilocarpine Hydrochloride Tablets, USP Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0527-1313-01 | Pilocarpine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 18 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0527-1313-01 | EA - Each | 0527-1313 | 4b383353-5002-49a4-b4ea-5bcd0afa7a80 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | AvPAK | b85547d8-fcec-323d-e053-2995a90a4e7e | 2026-01-09 | Warnings, Adverse reactions | 077220 ANDA077220 |
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | Bryant Ranch Prepack | 06c054af-62b4-4373-813a-9bb2e5c92316 | 2024-12-12 | Warnings, Adverse reactions | 077220 ANDA077220 |
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | Bryant Ranch Prepack | fb97323d-acec-4e4a-af16-efef66d969dc | 2024-12-06 | Warnings, Adverse reactions | 077220 ANDA077220 |
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | Lannett Company, Inc. | 8db0db4f-55ad-46b2-af50-e71b4a763aaa | 2024-10-18 | Warnings, Adverse reactions | 077220 ANDA077220 0527-1313 |
| Pilocarpine Hydrochloride | PILOCARPINE HYDROCHLORIDE | Bryant Ranch Prepack | 6a73a702-c5e2-44ea-81c8-ee7e60852c41 | 2024-03-22 | Warnings, Adverse reactions | 077220 ANDA077220 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1000913 | pilocarpine HCl 5 MG Oral Tablet | PSN | 6a73a702-c5e2-44ea-81c8-ee7e60852c41 | 105 |
| 1000913 | pilocarpine hydrochloride 5 MG Oral Tablet | SCD | 6a73a702-c5e2-44ea-81c8-ee7e60852c41 | 105 |
| 1000913 | pilocarpine HCl 5 MG Oral Tablet | PSN | 06c054af-62b4-4373-813a-9bb2e5c92316 | 101 |
| 1000913 | pilocarpine hydrochloride 5 MG Oral Tablet | SCD | 06c054af-62b4-4373-813a-9bb2e5c92316 | 101 |
| 1000913 | pilocarpine HCl 5 MG Oral Tablet | PSN | 8db0db4f-55ad-46b2-af50-e71b4a763aaa | 18 |
| 1001004 | pilocarpine HCl 7.5 MG Oral Tablet | PSN | 8db0db4f-55ad-46b2-af50-e71b4a763aaa | 18 |
| 1000913 | pilocarpine hydrochloride 5 MG Oral Tablet | SCD | 8db0db4f-55ad-46b2-af50-e71b4a763aaa | 18 |
| 1001004 | pilocarpine hydrochloride 7.5 MG Oral Tablet | SCD | 8db0db4f-55ad-46b2-af50-e71b4a763aaa | 18 |
| 1000913 | pilocarpine HCl 5 MG Oral Tablet | PSN | b85547d8-fcec-323d-e053-2995a90a4e7e | 4 |
| 1000913 | pilocarpine hydrochloride 5 MG Oral Tablet | SCD | b85547d8-fcec-323d-e053-2995a90a4e7e | 4 |
| 1000913 | pilocarpine HCl 5 MG Oral Tablet | PSN | fb97323d-acec-4e4a-af16-efef66d969dc | 2 |
| 1000913 | pilocarpine hydrochloride 5 MG Oral Tablet | SCD | fb97323d-acec-4e4a-af16-efef66d969dc | 2 |
| 1000913 | pilocarpine HCl 5 MG Oral Tablet | PSN | ecd2428e-b471-4dba-9b22-a81af4065d5a | 1 |
| 1000913 | pilocarpine hydrochloride 5 MG Oral Tablet | SCD | ecd2428e-b471-4dba-9b22-a81af4065d5a | 1 |
Packages#
| 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 |