Protopam Chloride

Product NDC: 60977-141
11-digit product format: 609770141
Labeler code: 60977
Product ID: 60977-141_ce0e8c50-0a21-4dbe-bdc6-e64a26a120c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pralidoxime chloride
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Baxter Healthcare Corporation
Application: NDA014134
Marketing category: NDA
Marketing start: 1965-03-10
Substance: PRALIDOXIME CHLORIDE
Active strength: 1 g/20mL
Pharmacologic classes: Cholinesterase Reactivator [EPC], Cholinesterase Reactivators [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N014134-001	PROTOPAM CHLORIDE	PRALIDOXIME CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N014134-001	PROTOPAM CHLORIDE	1GM/VIAL	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Protopam Chloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRALIDOXIME CHLORIDE	1 g/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
38X7XS076H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
208969	Internal RxNorm lookup
312576	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2741d8fd-51c2-46be-880b-99f2b20a6137	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca	Product name	1	20230719
0395ee9f-b6e0-2e52-6ab9-39f69ba534d5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60977-141-01	Protopam Chloride	6 in 1 PACKAGE	INJECTION, POWDER, LYOPHILIZED,	6		15
60977-141-27	Protopam Chloride	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	20		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60977-141-01	EA - Each	60977-141	d5af37da-bdf1-425c-9bff-87ca8be75b31	1	2012-07-24
60977-141-27	EA - Each	60977-141	a9c49cb0-136b-46b5-8273-25400b4dd281	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRALIDOXIME CHLORIDE	ACTIVE INGREDIENT	38X7XS076H	PROTOPAM CHLORIDE (PRALIDOXIME CHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]	5
PRALIDOXIME	ACTIVE MOIETY	P7MU9UTP52	PROTOPAM CHLORIDE (PRALIDOXIME CHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PROTOPAM CHLORIDE (PRALIDOXIME CHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60977-141	PROTOPAM CHLORIDE (PRALIDOXIME CHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]	14	Current NDC, Legacy NDC, 2 package rows	20250228_2741d8fd-51c2-46be-880b-99f2b20a6137.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
Protopam Chloride	PRALIDOXIME CHLORIDE	Baxter Healthcare Corporation	2741d8fd-51c2-46be-880b-99f2b20a6137	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 014134 application number: NDA014134 ndc (product): 60977-141

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
38X7XS076H	PRALIDOXIME CHLORIDE	14018-50-9	PRALIDOXIME CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312576	pralidoxime chloride 1 GM Injection	PSN	2741d8fd-51c2-46be-880b-99f2b20a6137	15
208969	Protopam Chloride 1 GM Injection	PSN	2741d8fd-51c2-46be-880b-99f2b20a6137	15
208969	pralidoxime chloride 1000 MG Injection [Protopam]	SBD	2741d8fd-51c2-46be-880b-99f2b20a6137	15
312576	pralidoxime chloride 1000 MG Injection	SCD	2741d8fd-51c2-46be-880b-99f2b20a6137	15
312576	pralidoxime chloride 1 GM Injection	SY	2741d8fd-51c2-46be-880b-99f2b20a6137	15
208969	Protopam 1 GM Injection	SY	2741d8fd-51c2-46be-880b-99f2b20a6137	15
208969	Protopam 1000 MG Injection	SY	2741d8fd-51c2-46be-880b-99f2b20a6137	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60977-141-01	60977014101	6 VIAL, SINGLE-DOSE in 1 PACKAGE (60977-141-01) / 20 mL in 1 VIAL, SINGLE-DOSE (60977-141-27)		1965-03-10	0000-00-00	No	No	Current
60977-141-27	60977014127	20 mL in 1 VIAL, SINGLE-DOSE	20 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROTOPAM (pralidoxime chloride) for Injection	Baxter Healthcare Corporation	2026-04-01	HUMAN PRESCRIPTION DRUG LABEL	15