Pilocarpine Hydrochloride

Product NDC: 10135-589
11-digit product format: 101350589
Labeler code: 10135
Product ID: 10135-589_a522e84d-00fe-458d-ad94-0c46d9f2ecf1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pilocarpine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA077220
Marketing category: ANDA
Marketing start: 2014-10-01
Marketing end: 0000-00-00
Substance: PILOCARPINE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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	10135-589		I	Inactivated by FDA		2026-08-03
excluded package	package	10135-589	10135-589-01	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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-589-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-589-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-589-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-589-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-589-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-589-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-589-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-589-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-589-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-589-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-589-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-589-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-589-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-589-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-589-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10135-589-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10135-589-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10135-589-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10135-589-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10135-589-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	10135-589-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	10135-589-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
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#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
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.

Product history page 1 of 3 · 82 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	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…`
2021-12-28 21:50 UTC	2021-12	A077220-001	PILOCARPINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2005-10-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077220-002	PILOCARPINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2009-05-06	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	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…`
2021-12-28 21:50 UTC	2021-12	A077220-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077220-002	AB	1	`782e0a99824c…`

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
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 table
NDC	Effective	Action	Document	Indexing SPL	Related label
10135-589-01	2020-01-31	C162847	48780-1	9d75b9d0-b2c6-f424-e053-dadaa90a57ce	Pilocarpine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-589-01	Pilocarpine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-589-01	EA - Each	10135-589	2a95cb8a-3ced-4690-b1cd-d79238362d88	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PILOCARPINE HYDROCHLORIDE	ACTIVE INGREDIENT	0WW6D218XJ	PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	1
PILOCARPINE	ACTIVE MOIETY	01MI4Q9DI3	PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	1
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-589	PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	1	Legacy NDC, 1 package rows	20150326_0bb77eb0-f518-41bc-8212-8bcd0e75510c.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 · 5 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (ANDA): 077220 application number: ANDA077220
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Bryant Ranch Prepack	06c054af-62b4-4373-813a-9bb2e5c92316	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077220 application number: ANDA077220
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Bryant Ranch Prepack	fb97323d-acec-4e4a-af16-efef66d969dc	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077220 application number: ANDA077220
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Lannett Company, Inc.	8db0db4f-55ad-46b2-af50-e71b4a763aaa	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077220 application number: ANDA077220
Pilocarpine Hydrochloride	PILOCARPINE HYDROCHLORIDE	Bryant Ranch Prepack	6a73a702-c5e2-44ea-81c8-ee7e60852c41	2024-03-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077220 application number: ANDA077220

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
1000913	pilocarpine HCl 5 MG Oral Tablet	PSN	0bb77eb0-f518-41bc-8212-8bcd0e75510c	1
1001004	pilocarpine HCl 7.5 MG Oral Tablet	PSN	0bb77eb0-f518-41bc-8212-8bcd0e75510c	1
1000913	pilocarpine hydrochloride 5 MG Oral Tablet	SCD	0bb77eb0-f518-41bc-8212-8bcd0e75510c	1
1001004	pilocarpine hydrochloride 7.5 MG Oral Tablet	SCD	0bb77eb0-f518-41bc-8212-8bcd0e75510c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10135-589-01	10135058901	100 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pilocarpine Hydrochloride Tablets, USP	Marlex Pharmaceuticals Inc	2015-03-12	HUMAN PRESCRIPTION DRUG LABEL	1