FDA.reportPublic FDA data

Nitroglycerin

Product NDC
68462-639
11-digit product format
684620639
Labeler code
68462
Product ID
68462-639_76e69387-efc6-4816-972c-765cb260b34a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA206391
Marketing category
ANDA
Marketing start
2017-09-19
Substance
NITROGLYCERIN
Active strength
.4 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206391-001NITROGLYCERINNITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2017-09-19
A206391-002NITROGLYCERINNITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2017-09-19
A206391-003NITROGLYCERINNITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2017-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A206391-001AB
A206391-002AB
A206391-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206391-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2017-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206391-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2017-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206391-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2017-09-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206391-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2017-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206391-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2017-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206391-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2017-09-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206391-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2017-09-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206391-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2017-09-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206391-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2017-09-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206391-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2017-09-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206391-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2017-09-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206391-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2017-09-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206391-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2017-09-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206391-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2017-09-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206391-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2017-09-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206391-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2017-09-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206391-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2017-09-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206391-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2017-09-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206391-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2017-09-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206391-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2017-09-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206391-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2017-09-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206391-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2017-09-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206391-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2017-09-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206391-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2017-09-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206391-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2017-09-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206391-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2017-09-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206391-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2017-09-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206391-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2017-09-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A206391-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2017-09-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A206391-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2017-09-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206391-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2017-09-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206391-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2017-09-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206391-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2017-09-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206391-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2017-09-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206391-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2017-09-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206391-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2017-09-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206391-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2017-09-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206391-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2017-09-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206391-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2017-09-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206391-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2017-09-198072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206391-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206391-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206391-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206391-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206391-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206391-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206391-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206391-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206391-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206391-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206391-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206391-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206391-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206391-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206391-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206391-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206391-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206391-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206391-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206391-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206391-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206391-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206391-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206391-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206391-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206391-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206391-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206391-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206391-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206391-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206391-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206391-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206391-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206391-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206391-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206391-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206391-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206391-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206391-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206391-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Nitroglycerin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN.4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G59M7S0WS3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198038Internal RxNorm lookup
198039Internal RxNorm lookup
198040Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fa789d65-9407-4965-bd06-4457444b42beAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
95250459-30e4-45c1-b08a-993044f49109Product name220250805
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
36390b75-5438-47d3-af60-732a654e9025Product name220220110
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
00358076-c817-430b-b924-11d717dc307cProduct name120160718
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-639-01Nitroglycerin1 in 1 CARTONTABLET110
68462-639-01Nitroglycerin100 in 1 BOTTLETABLET10010
68462-639-25Nitroglycerin25 in 1 BOTTLETABLET2510
68462-639-45Nitroglycerin4 in 1 CARTONTABLET410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-639-01EA - Each68462-6397820ef12-2457-4012-b5e4-c16dc4cab01312017-10-13
68462-639-25EA - Each68462-6393e60aeb8-804d-41d8-8ff2-57997d3192f212017-11-06
68462-639-45EA - Each68462-6394f9ffd20-f35e-4cd4-882b-fac08857c64612017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-639NITROGLYCERIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]9Current NDC, Legacy NDC, 4 package rows20240104_fa789d65-9407-4965-bd06-4457444b42be.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitroglycerinNITROGLYCERINA-S Medication Solutions532e30c4-cbda-4450-b0a0-e08601c202fb2026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206391
application number: ANDA206391
NitroglycerinNITROGLYCERINGlenmark Pharmaceuticals Inc., USAfa789d65-9407-4965-bd06-4457444b42be2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206391
application number: ANDA206391
ndc (product): 68462-639
NitroglycerinNITROGLYCERINProPharma Distribution3d71f76d-bb22-7251-e063-6394a90aa9d82025-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206391
application number: ANDA206391
NitroglycerinNITROGLYCERINNuCare Pharmaceuticals, Inc.2bad7976-4eb0-d064-e063-6394a90a75de2025-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206391
application number: ANDA206391
NitroglycerinNITROGLYCERINProficient Rx LP41fe1f25-bfd0-4eaf-973d-bdb6b5d70f932024-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206391
application number: ANDA206391
NitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC8959095a-8cd8-f7d4-e053-2995a90a6e8f2023-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206391
application number: ANDA206391

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198038nitroglycerin 0.3 MG Sublingual TabletPSNfa789d65-9407-4965-bd06-4457444b42be10
198039nitroglycerin 0.4 MG Sublingual TabletPSNfa789d65-9407-4965-bd06-4457444b42be10
198040nitroglycerin 0.6 MG Sublingual TabletPSNfa789d65-9407-4965-bd06-4457444b42be10
198038nitroglycerin 0.3 MG Sublingual TabletSCDfa789d65-9407-4965-bd06-4457444b42be10
198039nitroglycerin 0.4 MG Sublingual TabletSCDfa789d65-9407-4965-bd06-4457444b42be10
198040nitroglycerin 0.6 MG Sublingual TabletSCDfa789d65-9407-4965-bd06-4457444b42be10
198038nitroglycerin 300 MCG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198039nitroglycerin 400 MCG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198040nitroglycerin 600 MCG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198038NTG 0.3 MG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198039NTG 0.4 MG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198040NTG 0.6 MG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198038TNG 0.3 MG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198039TNG 0.4 MG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198040TNG 0.6 MG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSNbae7a52f-504b-416e-afdd-e6853e2d59445
212033aspirin 325 MG Oral TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
211874BAYER Aspirin 325 MG Oral TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1870225EPINEPHrine (generic for Adrenaclick) 0.15 MG in 0.15 ML Auto-InjectorPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSNbae7a52f-504b-416e-afdd-e6853e2d59445
310519glucose 4 GM Chewable TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
198039nitroglycerin 0.4 MG Sublingual TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
211874aspirin 325 MG Oral Tablet [Bayer Aspirin]SBDbae7a52f-504b-416e-afdd-e6853e2d59445
212033aspirin 325 MG Oral TabletSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCDbae7a52f-504b-416e-afdd-e6853e2d59445
310519glucose 4000 MG Chewable TabletSCDbae7a52f-504b-416e-afdd-e6853e2d59445
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1870225NDA020800 0.15 ML epinephrine 1 MG/ML Auto-InjectorSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCDbae7a52f-504b-416e-afdd-e6853e2d59445
198039nitroglycerin 0.4 MG Sublingual TabletSCDbae7a52f-504b-416e-afdd-e6853e2d59445
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSYbae7a52f-504b-416e-afdd-e6853e2d59445
212033ASA 325 MG Oral TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
211874ASA 325 MG Oral Tablet [Bayer Aspirin]SYbae7a52f-504b-416e-afdd-e6853e2d59445
211874Bayer Aspirin 325 MG Oral TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1870225epinephrine (generic for Adrenaclick) 0.15 MG per 0.15 ML Auto-InjectorSYbae7a52f-504b-416e-afdd-e6853e2d59445
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSYbae7a52f-504b-416e-afdd-e6853e2d59445
310519glucose 4 GM Chewable TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
198039nitroglycerin 400 MCG Sublingual TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
198039NTG 0.4 MG Sublingual TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
198039TNG 0.4 MG Sublingual TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSN58d78805-3e8c-4859-b2e0-e3089f9252804
212033aspirin 325 MG Oral TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
211874BAYER Aspirin 325 MG Oral TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSN58d78805-3e8c-4859-b2e0-e3089f9252804
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSN58d78805-3e8c-4859-b2e0-e3089f9252804
310519glucose 4 GM Chewable TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
198039nitroglycerin 0.4 MG Sublingual TabletPSN532e30c4-cbda-4450-b0a0-e08601c202fb4
198039nitroglycerin 0.4 MG Sublingual TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
211874aspirin 325 MG Oral Tablet [Bayer Aspirin]SBD58d78805-3e8c-4859-b2e0-e3089f9252804
212033aspirin 325 MG Oral TabletSCD58d78805-3e8c-4859-b2e0-e3089f9252804
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCD58d78805-3e8c-4859-b2e0-e3089f9252804
310519glucose 4000 MG Chewable TabletSCD58d78805-3e8c-4859-b2e0-e3089f9252804
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD58d78805-3e8c-4859-b2e0-e3089f9252804
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD58d78805-3e8c-4859-b2e0-e3089f9252804
198039nitroglycerin 0.4 MG Sublingual TabletSCD58d78805-3e8c-4859-b2e0-e3089f9252804
198039nitroglycerin 0.4 MG Sublingual TabletSCD532e30c4-cbda-4450-b0a0-e08601c202fb4
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSY58d78805-3e8c-4859-b2e0-e3089f9252804
212033ASA 325 MG Oral TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
211874ASA 325 MG Oral Tablet [Bayer Aspirin]SY58d78805-3e8c-4859-b2e0-e3089f9252804
211874Bayer Aspirin 325 MG Oral TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSY58d78805-3e8c-4859-b2e0-e3089f9252804
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSY58d78805-3e8c-4859-b2e0-e3089f9252804
310519glucose 4 GM Chewable TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
198039nitroglycerin 400 MCG Sublingual TabletSY532e30c4-cbda-4450-b0a0-e08601c202fb4
198039nitroglycerin 400 MCG Sublingual TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
198039NTG 0.4 MG Sublingual TabletSY532e30c4-cbda-4450-b0a0-e08601c202fb4
198039NTG 0.4 MG Sublingual TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
198039TNG 0.4 MG Sublingual TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
198039TNG 0.4 MG Sublingual TabletSY532e30c4-cbda-4450-b0a0-e08601c202fb4
313782acetaminophen 325 MG Oral TabletPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
2123076albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for VentolinPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSN9ef8edbd-047a-40fe-a603-d71fce8ada683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-639-01684620639011 BOTTLE in 1 CARTON (68462-639-01) / 100 TABLET in 1 BOTTLE1 bottle2017-09-190000-00-00NoNoCurrent
68462-639-256846206392525 in 1 BOTTLEHistorical
68462-639-45684620639454 BOTTLE in 1 CARTON (68462-639-45) / 25 TABLET in 1 BOTTLE (68462-639-25) 4 bottle2017-09-190000-00-00NoNoCurrent