R-Gene

Product NDC: 0009-0436
11-digit product format: 000090436
Labeler code: 0009
Product ID: 0009-0436_92dc2b43-3599-4859-b08b-29c024171f08
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Arginine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Pharmacia & Upjohn Company LLC
Application: NDA016931
Marketing category: NDA
Marketing start: 1976-06-15
Substance: ARGININE HYDROCHLORIDE
Active strength: 10 g/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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
N016931-001	R-GENE 10	ARGININE HYDROCHLORIDE	10GM/100ML	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	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016931-001	R-GENE 10	10GM/100ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: R-Gene
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARGININE HYDROCHLORIDE	10 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F7LTH1E20Y	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
6accf33f-9841-4327-8923-93c42020ef12	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0009-0436-01	R-Gene	1 in 1 CARTON	INJECTION, SOLUTION	1		18
0009-0436-01	R-Gene	300 mL in 1 CONTAINER	INJECTION, SOLUTION	300		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0009-0436-01	ML - Milliliter	0009-0436	7d39fd96-d043-4bbe-89b2-63ae71b2eea1	1	2013-03-03
0009-0436-24	ML - Milliliter	0009-0436	1f3a382d-ea60-4c2c-b2a1-35bcf5a874d5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ARGININE HYDROCHLORIDE	ACTIVE INGREDIENT	F7LTH1E20Y	R-GENE (ARGININE HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	8
ARGININE	ACTIVE MOIETY	94ZLA3W45F	R-GENE (ARGININE HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	8
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	R-GENE (ARGININE HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	R-GENE (ARGININE HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0009-0436	R-GENE (ARGININE HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]	18	Current NDC, Legacy NDC, 2 package rows	20240403_6accf33f-9841-4327-8923-93c42020ef12.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
R-Gene	ARGININE HYDROCHLORIDE	Pharmacia & Upjohn Company LLC	6accf33f-9841-4327-8923-93c42020ef12	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016931 application number: NDA016931 ndc (product): 0009-0436

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F7LTH1E20Y	ARGININE HYDROCHLORIDE	1119-34-2	ARGININE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0009-0436-01	00009043601	1 CONTAINER in 1 CARTON (0009-0436-01) / 300 mL in 1 CONTAINER	1 container	1976-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
R-Gene ® 10 Arginine Hydrochloride Injection, USP	Pharmacia & Upjohn Company LLC \| Pfizer Inc	2024-04-02	HUMAN PRESCRIPTION DRUG LABEL	18