Glycine

Product NDC
0990-7974
11-digit product format
009907974
Labeler code
0990
Product ID
0990-7974_3a1d66ff-c0ec-45f7-8c0a-df8dbc7f0cf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYCINE
Dosage form
IRRIGANT
Route
IRRIGATION
Labeler
ICU Medical Inc.
Application
NDA018315
Marketing category
NDA
Marketing start
2019-07-01
Substance
GLYCINE
Active strength
1.5 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018315-001GLYCINE 1.5% IN PLASTIC CONTAINERGLYCINE1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018315-001AT

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018315-001GLYCINE 1.5% IN PLASTIC CONTAINER1.5GM/100MLSOLUTION / IRRIGATIONATApproved before 1982e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018315-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018315-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018315-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018315-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018315-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018315-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018315-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018315-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018315-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018315-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018315-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018315-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018315-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018315-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018315-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018315-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018315-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018315-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018315-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018315-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018315-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018315-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N018315-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018315-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018315-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018315-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N018315-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018315-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018315-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018315-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018315-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018315-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018315-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018315-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018315-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018315-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018315-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018315-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018315-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018315-001AT1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCINE1.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TE7660XO1CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310571Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c10a4657-cf64-4a71-a247-363dd58993bcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0990-7974-08Glycine4 in 1 CASEIRRIGANT48
0990-7974-08Glycine1 in 1 POUCHIRRIGANT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-7974-08ML - Milliliter0990-79748f3c9366-f88d-4c88-830f-dcf410f0adae12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-7974GLYCINE IRRIGANT [ICU MEDICAL INC.]6Current NDC, Legacy NDC, 2 package rows20230421_c10a4657-cf64-4a71-a247-363dd58993bc.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
GlycineGLYCINEICU Medical Inc.c10a4657-cf64-4a71-a247-363dd58993bc2025-10-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 018315
application number: NDA018315
ndc (product): 0990-7974

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310571glycine 1.5 % Irrigation SolutionPSNc10a4657-cf64-4a71-a247-363dd58993bc8
310571glycine 15 MG/ML Irrigation SolutionSCDc10a4657-cf64-4a71-a247-363dd58993bc8
310571glycine 1.5 % Irrigation SolutionSYc10a4657-cf64-4a71-a247-363dd58993bc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-7974-08009907974084 POUCH in 1 CASE (0990-7974-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG4 pouch2019-07-010000-00-00NoNoCurrent