Pilocarpine Hydrochloride

Product NDC: 60219-1745
11-digit product format: 602191745
Labeler code: 60219
Product ID: 60219-1745_7455b927-9b9a-45ef-aa8c-4be1961bd58b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pilocarpine Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA214193
Marketing category: ANDA
Marketing start: 2020-09-23
Marketing end: 0000-00-00
Substance: PILOCARPINE HYDROCHLORIDE
Active strength: 10 mg/mL
Pharmacologic classes: Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60219-1745		I	Inactivated by FDA		2026-08-03
excluded package	package	60219-1745	60219-1745-8	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60219-1745-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60219-1745-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60219-1745-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60219-1745-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60219-1745-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60219-1745-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60219-1745-8	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60219-1745-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60219-1745-8	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60219-1745-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60219-1745-8	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60219-1745-8	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	60219-1745-8	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	60219-1745-8	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	60219-1745-8	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	60219-1745-8	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	60219-1745-8	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	60219-1745-8	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214193-001	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21
A214193-002	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21
A214193-003	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A214193-001	AT
A214193-002	AT
A214193-003	AT

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.

Product history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION/DROPS / OPHTHALMIC	AT	2020-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214193-002	PILOCARPINE HYDROCHLORIDE	2%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214193-003	PILOCARPINE HYDROCHLORIDE	4%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214193-001	PILOCARPINE HYDROCHLORIDE	1%	SOLUTION / OPHTHALMIC	AT	2020-09-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214193-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214193-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214193-003	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214193-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214193-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214193-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214193-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214193-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214193-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214193-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214193-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214193-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214193-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214193-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214193-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214193-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214193-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214193-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214193-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214193-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214193-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214193-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214193-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214193-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214193-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214193-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214193-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214193-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214193-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214193-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214193-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214193-002	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214193-003	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214193-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214193-002	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214193-003	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214193-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214193-002	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214193-003	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214193-001	AT	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
92fc48b4-3815-4611-a8be-f74b29f9b350	Product name	2	20260130
c8f45a17-34ae-46eb-871b-470615085910	Product name	1	20250630
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
dad00d81-2cbe-bbab-dd06-a12043b5e56d	Product name	4	20210512
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
419b812f-d1a6-2de2-5dee-bec68d6ec699	Product name	2	20200123
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
38c480e0-b6d3-b416-6514-a787406e5176	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60219-1745-8	2022-01-28	C162847	48780-1	d6a99b39-7c70-a426-e053-dadaa90af4c2	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 Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60219-1745-8	Pilocarpine Hydrochloride	15 mL in 1 BOTTLE	SOLUTION/ DROPS	15		8
60219-1745-8	Pilocarpine Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60219-1745	PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [AMNEAL PHARMACEUTICALS NY LLC]	8	Legacy NDC, 2 package rows	20200923_0b138939-7472-449f-b491-ae923924b8b6.zip

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	1e87a81a-7084-4436-918b-a50451534307	2021-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214193 application number: ANDA214193

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0WW6D218XJ	PILOCARPINE HYDROCHLORIDE	54-71-7	PILOCARPINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000647	pilocarpine HCl 1 % Ophthalmic Solution	PSN	0b138939-7472-449f-b491-ae923924b8b6	8
1000862	pilocarpine HCl 2 % Ophthalmic Solution	PSN	0b138939-7472-449f-b491-ae923924b8b6	8
1000897	pilocarpine HCl 4 % Ophthalmic Solution	PSN	0b138939-7472-449f-b491-ae923924b8b6	8
1000647	pilocarpine hydrochloride 10 MG/ML Ophthalmic Solution	SCD	0b138939-7472-449f-b491-ae923924b8b6	8
1000862	pilocarpine hydrochloride 20 MG/ML Ophthalmic Solution	SCD	0b138939-7472-449f-b491-ae923924b8b6	8
1000897	pilocarpine hydrochloride 40 MG/ML Ophthalmic Solution	SCD	0b138939-7472-449f-b491-ae923924b8b6	8
1000647	pilocarpine hydrochloride 1 % Ophthalmic Solution	SY	0b138939-7472-449f-b491-ae923924b8b6	8
1000862	pilocarpine hydrochloride 2 % Ophthalmic Solution	SY	0b138939-7472-449f-b491-ae923924b8b6	8
1000897	pilocarpine hydrochloride 4 % Ophthalmic Solution	SY	0b138939-7472-449f-b491-ae923924b8b6	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60219-1745-8	60219174508	1 BOTTLE in 1 CARTON (60219-1745-8) > 15 mL in 1 BOTTLE	1 bottle	2020-09-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pilocarpine Hydrochloride	Amneal Pharmaceuticals NY LLC	2020-09-22	HUMAN PRESCRIPTION DRUG LABEL	8