Application 201370

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/ML	Yes	Yes
002	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	5,000 UNITS/ML	Yes	Yes
003	HEPARIN SODIUM	HEPARIN SODIUM	INJECTABLE;INJECTION	10,000 UNITS/ML	Yes	Yes
004	HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	INJECTABLE;INJECTION	1,000 UNITS/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N201370-001	HEPARIN SODIUM	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD	2011-07-21
N201370-002	HEPARIN SODIUM	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RLD	2011-07-21
N201370-003	HEPARIN SODIUM	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	RLD	2011-07-21
N201370-004	HEPARIN SODIUM PRESERVATIVE FREE	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N201370-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201370-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201370-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N201370-004	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201370-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201370-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201370-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	RLD	2011-07-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N201370-004	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201370-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201370-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201370-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	RLD	2011-07-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N201370-004	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201370-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201370-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201370-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	RLD	2011-07-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201370-004	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201370-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N201370-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N201370-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	RLD	2011-07-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N201370-004	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201370-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201370-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201370-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	RLD	2011-07-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N201370-004	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201370-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N201370-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N201370-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	RLD	2011-07-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N201370-004	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201370-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N201370-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N201370-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N201370-004	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201370-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N201370-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N201370-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N201370-004	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201370-001	HEPARIN SODIUM	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N201370-002	HEPARIN SODIUM	5,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N201370-003	HEPARIN SODIUM	10,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N201370-004	HEPARIN SODIUM PRESERVATIVE FREE	1,000 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2011-07-21	`ea99ee380514…`

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
Heparin Sodium	HEPARIN SODIUM	Pfizer Laboratories Div Pfizer Inc	56dc3074-f1c5-45a3-b923-f1d14858e06d	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201370 application number: NDA201370 ndc (product): 0069-0058 ndc (product): 0069-0043 ndc (product): 0069-0062 ndc (product): 0069-0059 ndc (product): 0069-0137

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0043	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0043	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0043	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0043	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0043	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0058	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0058	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0058	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0058	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0058	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0059	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0059	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0059	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0059	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0059	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0062	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0062	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0062	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0062	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0137	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0137	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0137	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0137	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0137	Heparin Sodium	Heparin Sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83532	SUPPL	2025-09-26
83524	SUPPL	2025-09-26
80011	SUPPL	2024-10-28
79996	SUPPL	2024-10-25
60080	SUPPL	2019-09-20
60079	SUPPL	2019-09-20
60074	SUPPL	2019-09-20
60073	SUPPL	2019-09-20
45035	SUPPL	2016-08-09
45019	SUPPL	2016-08-09
44836	ORIG	2012-06-20
43365	ORIG	2012-06-20
40068	ORIG	2011-07-25
32109	ORIG	2011-07-25