Home NDC 0409-1316-32 Heparin Sodium
Product NDC 0409-1316
Requested package NDC 0409-1316-32
11-digit product format 004091316
Labeler code 0409
Product ID 0409-1316_c1c9f0cd-53e6-453b-a96a-0d6f0fe2648d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HEPARIN SODIUM
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Hospira, Inc.
Application ANDA089522
Marketing category ANDA
Marketing start 2005-03-31
Substance HEPARIN SODIUM
Active strength 10000 [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 43 .
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 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089522-001 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 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION RS 1987-05-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION 1987-05-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION RS 1987-05-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION RS 1987-05-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION RS 1987-05-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089522-001 HEPARIN SODIUM PRESERVATIVE FREE 10,000 UNITS/ML INJECTABLE / INJECTION AP 1987-05-04 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Heparin Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HEPARIN SODIUM 10000 [USP'U]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZZ45AB24CA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1361853 Internal RxNorm lookup 1659260 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-1316-11 Heparin Sodium 0.5 mL in 1 CARTRIDGE INJECTION, SOLUTION 0.5 23 0409-1316-32 Heparin Sodium 50 in 1 CONTAINER INJECTION, SOLUTION 50 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HEPARIN SODIUM ACTIVE INGREDIENT ZZ45AB24CA HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 9 HEPARIN ACTIVE MOIETY T2410KM04A HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 9 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 9 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 9 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 9 WATER INACTIVE INGREDIENT 059QF0KO0R HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 9 HEPARIN SODIUM ACTIVE INGREDIENT ZZ45AB24CA HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH] 7 Heparin ACTIVE MOIETY T2410KM04A HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH] 7 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH] 7 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH] 7 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH] 7 WATER INACTIVE INGREDIENT 059QF0KO0R HEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1316 HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 21 Current NDC, Legacy NDC, 2 package rows 20241207_c8c4edd2-ee9e-4558-6b8c-b83adc242a0a.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.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1361853 heparin sodium, porcine 5000 UNT in 0.5 ML Cartridge PSN c8c4edd2-ee9e-4558-6b8c-b83adc242a0a 23 1659260 heparin sodium, porcine 5000 UNT in 1 ML Cartridge PSN c8c4edd2-ee9e-4558-6b8c-b83adc242a0a 23 1361853 0.5 ML heparin sodium, porcine 10000 UNT/ML Cartridge SCD c8c4edd2-ee9e-4558-6b8c-b83adc242a0a 23 1659260 1 ML heparin sodium, porcine 5000 UNT/ML Cartridge SCD c8c4edd2-ee9e-4558-6b8c-b83adc242a0a 23 1361853 heparin sodium, porcine 5000 UNT per 0.5 ML Cartridge SY c8c4edd2-ee9e-4558-6b8c-b83adc242a0a 23 1659260 heparin sodium, porcine 5000 UNT per 1 ML Cartridge SY c8c4edd2-ee9e-4558-6b8c-b83adc242a0a 23 1361853 heparin sodium, porcine 5000 UNT in 0.5 ML Cartridge PSN 9ea0a519-dc7c-42e3-939e-2a7c80eedd25 16 1361853 0.5 ML heparin sodium, porcine 10000 UNT/ML Cartridge SCD 9ea0a519-dc7c-42e3-939e-2a7c80eedd25 16 1361853 heparin sodium, porcine 5000 UNT per 0.5 ML Cartridge SY 9ea0a519-dc7c-42e3-939e-2a7c80eedd25 16
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0409-1316-32 00409131632 50 CARTRIDGE in 1 CONTAINER (0409-1316-32) / .5 mL in 1 CARTRIDGE (0409-1316-11) 50 cartridge 2005-03-31 0000-00-00 No No Current