Heparin Sodium

Product NDC
0069-0137
11-digit product format
000690137
Labeler code
0069
Product ID
0069-0137_402dbe94-888a-4e23-ba4b-b910f15c31e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA201370
Marketing category
NDA
Marketing start
2013-03-11
Marketing end
0000-00-00
Substance
HEPARIN SODIUM
Active strength
1000 [USP'U]/mL
Pharmacologic classes
Anti-coagulant [EPC],Heparin [CS],Unfractionated Heparin [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0069-0137DDiscontinued by firm2026-08-10
excluded packagepackage0069-01370069-0137-03DDiscontinued by firm2026-08-10

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0069-0137-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0069-0137-03f5e01cc5f278…a2eaf40c39c3…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N201370-001HEPARIN SODIUMHEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-21
N201370-002HEPARIN SODIUMHEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-21
N201370-003HEPARIN SODIUMHEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-21
N201370-004HEPARIN SODIUM PRESERVATIVE FREEHEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-21

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 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N201370-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201370-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201370-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201370-004HEPARIN SODIUM PRESERVATIVE FREE1,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201370-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201370-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201370-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201370-004HEPARIN SODIUM PRESERVATIVE FREE1,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N201370-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201370-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201370-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201370-004HEPARIN SODIUM PRESERVATIVE FREE1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201370-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201370-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201370-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201370-004HEPARIN SODIUM PRESERVATIVE FREE1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201370-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201370-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201370-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201370-004HEPARIN SODIUM PRESERVATIVE FREE1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201370-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201370-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201370-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201370-004HEPARIN SODIUM PRESERVATIVE FREE1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201370-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201370-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201370-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201370-004HEPARIN SODIUM PRESERVATIVE FREE1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201370-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201370-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201370-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201370-004HEPARIN SODIUM PRESERVATIVE FREE1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201370-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201370-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201370-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201370-004HEPARIN SODIUM PRESERVATIVE FREE1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N201370-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N201370-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N201370-003HEPARIN SODIUM10,000 UNITS/MLINJECTABLE / INJECTIONRLD2011-07-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N201370-004HEPARIN SODIUM PRESERVATIVE FREE1,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS2011-07-21d06236e962d9…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac74f96-3910-44b9-8551-036880fbb1fbProduct name120260108
0a18eae4-4259-42db-86b6-915f66e83b06Product name120250729
2c999b01-2a13-4eff-8eb4-00b87316ef79Product name120231116
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0137-01Heparin Sodium30 mL in 1 VIALINJECTION3032
0069-0137-03Heparin Sodium10 in 1 CARTONINJECTION1032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0137-01ML - Milliliter0069-013731409cf9-d5f0-4a65-b689-f8f5cdc4460d12013-10-17
0069-0137-03ML - Milliliter0069-0137cdebc9d8-37a1-4ea0-affd-ea04b8ddbf4b12013-10-17

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0137HEPARIN SODIUM INJECTION [PFIZER LABORATORIES DIV PFIZER INC]29Legacy NDC, 2 package rows20241004_56dc3074-f1c5-45a3-b923-f1d14858e06d.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Heparin SodiumHEPARIN SODIUMPfizer Laboratories Div Pfizer Inc56dc3074-f1c5-45a3-b923-f1d14858e06d2025-10-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 201370
application number: NDA201370
ndc (product): 0069-0137

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionPSN56dc3074-f1c5-45a3-b923-f1d14858e06d32
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSN56dc3074-f1c5-45a3-b923-f1d14858e06d32
1658647heparin sodium, porcine 2000 UNT in 2 ML InjectionPSN56dc3074-f1c5-45a3-b923-f1d14858e06d32
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSN56dc3074-f1c5-45a3-b923-f1d14858e06d32
16586472 ML heparin sodium, porcine 1000 UNT/ML InjectionSCD56dc3074-f1c5-45a3-b923-f1d14858e06d32
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCD56dc3074-f1c5-45a3-b923-f1d14858e06d32
1362831heparin sodium, porcine 10000 UNT/ML Injectable SolutionSCD56dc3074-f1c5-45a3-b923-f1d14858e06d32
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCD56dc3074-f1c5-45a3-b923-f1d14858e06d32
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionSY56dc3074-f1c5-45a3-b923-f1d14858e06d32
1658647heparin sodium, porcine 2000 UNT per 2 ML InjectionSY56dc3074-f1c5-45a3-b923-f1d14858e06d32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-0137-010006901370130 mL in 1 VIAL30 mlHistorical
0069-0137-030006901370310 VIAL in 1 CARTON (0069-0137-03) > 30 mL in 1 VIAL (0069-0137-01) 10 vial2013-03-110000-00-00NoNoCurrent