Heparin Sodium

Product NDC
87188-102
Requested package NDC
87188-102-90
11-digit product format
871880102
Labeler code
87188
Product ID
87188-102_4deaa9b8-9a35-cefc-e063-6394a90a0aa9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Plano Pharmaceuticals Inc.
Application
ANDA091682
Marketing category
ANDA
Marketing start
2011-06-08
Substance
HEPARIN SODIUM
Active strength
5000 [USP'U]/mL
Pharmacologic classes
Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091682-001HEPARIN SODIUMHEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08
A091682-002HEPARIN SODIUMHEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A091682-001AP
A091682-002AP

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091682-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08782e0a99824c…
2021-12-28 21:50 UTC2021-12A091682-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2011-06-08782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091682-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091682-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091682-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091682-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091682-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091682-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091682-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091682-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091682-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091682-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091682-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091682-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091682-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091682-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091682-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091682-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091682-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091682-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091682-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091682-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091682-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091682-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091682-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091682-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091682-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091682-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091682-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091682-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091682-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091682-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091682-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091682-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091682-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091682-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091682-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091682-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091682-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091682-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091682-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091682-002AP1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Heparin Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM5000 [USP'U]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZZ45AB24CAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1361615Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4deaa9ac-91aa-d96b-e063-6294a90a47bdAvailable on FDA.report

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
87188-102-01Heparin Sodium1 mL in 1 VIAL, MULTI-DOSEINJECTION11
87188-102-90Heparin Sodium25 in 1 CARTONINJECTION251

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 SODIUMPlano Pharmaceuticals Inc.4deaa9ac-91aa-d96b-e063-6294a90a47bd2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091682
application number: ANDA091682
ndc (package): 87188-102-90
ndc (product): 87188-102
ndc11 (package): 87188010290

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSN4deaa9ac-91aa-d96b-e063-6294a90a47bd1
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCD4deaa9ac-91aa-d96b-e063-6294a90a47bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87188-102-908718801029025 VIAL, MULTI-DOSE in 1 CARTON (87188-102-90) / 1 mL in 1 VIAL, MULTI-DOSE (87188-102-01) 2016-12-08NoNoCurrent