Dopram

Product NDC: 0641-6018
11-digit product format: 006416018
Labeler code: 0641
Product ID: 0641-6018_ccb9f1b7-b7b1-4db2-b5db-093d147529a7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxapram hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: NDA014879
Marketing category: NDA
Marketing start: 1965-06-23
Substance: DOXAPRAM HYDROCHLORIDE
Active strength: 20 mg/mL
Pharmacologic classes: Increased Medullary Respiratory Drive [PE], Respiratory Stimulant [EPC]
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 1.

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
N014879-001	DOPRAM	DOXAPRAM HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N014879-001	AP

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N014879-001	DOPRAM	20MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N014879-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N014879-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N014879-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N014879-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N014879-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N014879-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N014879-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N014879-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N014879-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N014879-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N014879-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N014879-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N014879-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N014879-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N014879-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N014879-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N014879-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N014879-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N014879-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N014879-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014879-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N014879-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N014879-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N014879-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N014879-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N014879-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N014879-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N014879-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N014879-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N014879-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N014879-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N014879-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N014879-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N014879-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N014879-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N014879-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N014879-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N014879-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N014879-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N014879-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXAPRAM HYDROCHLORIDE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P5RU6UOQ5Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1047087	Internal RxNorm lookup
1047511	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
b8eb330a-a75b-46cb-b694-5be9327ed2eb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7fed9301-0c64-3f05-8673-b9784e7ea65a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6018-01	Dopram	20 mL in 1 VIAL	INJECTION	20		6
0641-6018-06	Dopram	6 in 1 CARTON	INJECTION	6		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6018-01	ML - Milliliter	0641-6018	28e7dea2-29ed-475f-bafc-3a075b8ae612	1	2012-07-24
0641-6018-06	ML - Milliliter	0641-6018	e51b6f70-f3ce-484b-8fbd-931ddb64ec11	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXAPRAM HYDROCHLORIDE	ACTIVE INGREDIENT	P5RU6UOQ5Y	DOPRAM (DOXAPRAM HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
DOXAPRAM	ACTIVE MOIETY	94F3830Q73	DOPRAM (DOXAPRAM HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	DOPRAM (DOXAPRAM HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DOPRAM (DOXAPRAM HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6018	DOPRAM (DOXAPRAM HYDROCHLORIDE) INJECTION [HIKMA PHARMACEUTICALS USA INC.]	6	Current NDC, Legacy NDC, 2 package rows	20240410_b8eb330a-a75b-46cb-b694-5be9327ed2eb.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXAPRAM HYDROCHLORIDE	DOXAPRAM HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	954859c0-a121-34d6-e053-2a95a90a1e19	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 014879 application number: NDA014879
Dopram	DOXAPRAM HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	b8eb330a-a75b-46cb-b694-5be9327ed2eb	2024-04-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 014879 application number: NDA014879 ndc (product): 0641-6018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P5RU6UOQ5Y	DOXAPRAM HYDROCHLORIDE	7081-53-0	DOXAPRAM HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1047511	Dopram 400 MG in 20 ML Injectable Solution	PSN	b8eb330a-a75b-46cb-b694-5be9327ed2eb	6
1047087	doxapram HCl 400 MG in 20 ML Injectable Solution	PSN	b8eb330a-a75b-46cb-b694-5be9327ed2eb	6
1047511	doxapram hydrochloride 20 MG/ML Injectable Solution [Dopram]	SBD	b8eb330a-a75b-46cb-b694-5be9327ed2eb	6
1047087	doxapram hydrochloride 20 MG/ML Injectable Solution	SCD	b8eb330a-a75b-46cb-b694-5be9327ed2eb	6
1047511	Dopram 20 MG/ML Injectable Solution	SY	b8eb330a-a75b-46cb-b694-5be9327ed2eb	6
1047511	Dopram 400 MG per 20 ML Injectable Solution	SY	b8eb330a-a75b-46cb-b694-5be9327ed2eb	6
1047511	DOPRAM-V 20 MG/ML Injectable Solution	SY	b8eb330a-a75b-46cb-b694-5be9327ed2eb	6
1047087	doxapram HCl 400 MG per 20 ML Injectable Solution	SY	b8eb330a-a75b-46cb-b694-5be9327ed2eb	6
1047087	doxapram HCl 400 MG in 20 ML Injectable Solution	PSN	954859c0-a121-34d6-e053-2a95a90a1e19	3
1047087	doxapram hydrochloride 20 MG/ML Injectable Solution	SCD	954859c0-a121-34d6-e053-2a95a90a1e19	3
1047087	doxapram HCl 400 MG per 20 ML Injectable Solution	SY	954859c0-a121-34d6-e053-2a95a90a1e19	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0641-6018-01	00641601801	20 mL in 1 VIAL (0641-6018-01)	20 ml	1965-06-23	0000-00-00	No	No	Current
0641-6018-06	00641601806	6 VIAL in 1 CARTON (0641-6018-06) / 20 mL in 1 VIAL (0641-6018-01)	6 vial	1965-06-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOPRAM INJECTION (DOXAPRAM HYDROCHLORIDE INJECTION, USP) 400 mg/20 mL (20 mg/mL) 20 mL VIAL BOXED	HF Acquisition Co LLC, DBA HealthFirst	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	3
DOPRAM Injection (doxapram hydrochloride injection, USP)	Hikma Pharmaceuticals USA Inc.	2024-04-09	HUMAN PRESCRIPTION DRUG LABEL	6