Home NDC 0409-7650 Heparin Sodium
Product NDC 0409-7650
11-digit product format 004097650
Labeler code 0409
Product ID 0409-7650_d0901cbd-34c8-44e8-ba05-8b84952a862c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HEPARIN SODIUM
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA018916
Marketing category NDA
Marketing start 2005-06-30
Substance HEPARIN SODIUM
Active strength 10000 [USP'U]/100mL
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 44 .
Orange Book products# Current product rows page 1 of 1 · 11 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018916-001 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% HEPARIN SODIUM 1,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 N018916-002 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 N018916-003 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 N018916-004 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% HEPARIN SODIUM 100 UNITS/ML INJECTABLE / INJECTION 1984-01-31 N018916-005 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 N018916-006 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 N018916-007 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 N018916-008 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 N018916-009 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 N018916-010 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23 N018916-011 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER HEPARIN SODIUM 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 13 · 484 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 2026-10-15 13:18:30 2026-09 N018916-001 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% 1,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-002 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-003 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-004 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% 100 UNITS/ML INJECTABLE / INJECTION 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-005 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-006 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-007 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-008 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 10,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-009 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-010 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N018916-011 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 N018916-001 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% 1,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-002 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-003 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-004 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% 100 UNITS/ML INJECTABLE / INJECTION 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-005 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-006 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-007 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-008 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 10,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-009 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-010 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018916-011 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018916-001 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% 1,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-002 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-003 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-004 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% 100 UNITS/ML INJECTABLE / INJECTION 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-005 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-006 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-007 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-008 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 10,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-009 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-010 HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018916-011 HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 200 UNITS/100ML INJECTABLE / INJECTION AP RLD, RS 1989-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018916-001 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% 1,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018916-002 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018916-003 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% 5,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018916-004 HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% 100 UNITS/ML INJECTABLE / INJECTION 1984-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018916-005 HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% 10,000 UNITS/100ML INJECTABLE / INJECTION 1984-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018916-006 HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018916-007 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION RLD, RS 1984-01-31 011fe1cb6892…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 88 observed states.
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]/100mL
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1658717 Internal RxNorm lookup 1659195 Internal RxNorm lookup 1659196 Internal RxNorm lookup 1659197 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 0409-7650-05 Heparin Sodium 250 mL in 1 BAG INJECTION, SOLUTION 250 31 0409-7650-30 Heparin Sodium 30 in 1 CASE INJECTION, SOLUTION 30 31 0409-7650-30 Heparin Sodium 1 in 1 POUCH INJECTION, SOLUTION 1 31 0409-7650-52 Heparin Sodium 250 mL in 1 BAG INJECTION, SOLUTION 250 31 0409-7650-62 Heparin Sodium 24 in 1 CASE INJECTION, SOLUTION 24 31 0409-7650-62 Heparin Sodium 1 in 1 POUCH INJECTION, SOLUTION 1 31
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.] 13 HEPARIN ACTIVE MOIETY T2410KM04A HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 13 EDETATE DISODIUM ANHYDROUS INACTIVE INGREDIENT 8NLQ36F6MM HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 13 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 13 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 13 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-7650 HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.] 28 Current NDC, Legacy NDC, 6 package rows 20241105_0413f511-6b34-4c15-e48b-3fad08baacbe.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 · 3 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1659197 heparin sodium, porcine 12,500 UNT in 250 ML Injection PSN 0413f511-6b34-4c15-e48b-3fad08baacbe 31 1658717 heparin sodium, porcine 25,000 UNT in 250 ML Injection PSN 0413f511-6b34-4c15-e48b-3fad08baacbe 31 1659195 heparin sodium, porcine 25,000 UNT in 500 ML Injection PSN 0413f511-6b34-4c15-e48b-3fad08baacbe 31 1658717 250 ML heparin sodium, porcine 100 UNT/ML Injection SCD 0413f511-6b34-4c15-e48b-3fad08baacbe 31 1659197 250 ML heparin sodium, porcine 50 UNT/ML Injection SCD 0413f511-6b34-4c15-e48b-3fad08baacbe 31 1659195 500 ML heparin sodium, porcine 50 UNT/ML Injection SCD 0413f511-6b34-4c15-e48b-3fad08baacbe 31 1659196 heparin sodium, porcine 50 UNT/ML Injection SCD 0413f511-6b34-4c15-e48b-3fad08baacbe 31 1659197 heparin sodium, porcine 12,500 UNT per 250 ML Injection SY 0413f511-6b34-4c15-e48b-3fad08baacbe 31 1658717 heparin sodium, porcine 25,000 UNT per 250 ML Injection SY 0413f511-6b34-4c15-e48b-3fad08baacbe 31 1659195 heparin sodium, porcine 25,000 UNT per 500 ML Injection SY 0413f511-6b34-4c15-e48b-3fad08baacbe 31 1658717 heparin sodium, porcine 25,000 UNT in 250 ML Injection PSN 97183edd-fa5c-8ff1-e053-2995a90ae1d5 5 1658717 250 ML heparin sodium, porcine 100 UNT/ML Injection SCD 97183edd-fa5c-8ff1-e053-2995a90ae1d5 5 1658717 heparin sodium, porcine 25,000 UNT per 250 ML Injection SY 97183edd-fa5c-8ff1-e053-2995a90ae1d5 5 1658717 heparin sodium, porcine 25,000 UNT in 250 ML Injection PSN 51197aa6-de34-3a55-e063-6294a90a89c9 1 1658717 250 ML heparin sodium, porcine 100 UNT/ML Injection SCD 51197aa6-de34-3a55-e063-6294a90a89c9 1 1658717 heparin sodium, porcine 25,000 UNT per 250 ML Injection SY 51197aa6-de34-3a55-e063-6294a90a89c9 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0409-7650-05 00409765005 250 mL in 1 BAG 250 ml Historical 0409-7650-30 00409765030 30 POUCH in 1 CASE (0409-7650-30) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-7650-05) 30 pouch 2023-01-30 No No Current 0409-7650-52 00409765052 250 mL in 1 BAG 250 ml Historical 0409-7650-62 00409765062 24 POUCH in 1 CASE (0409-7650-62) > 1 BAG in 1 POUCH > 250 mL in 1 BAG (0409-7650-52) 24 pouch 2005-06-30 0000-00-00 No No Current