Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
Direct_Rx
ORAL
PRESCRIPTION DRUG
300 mg Capsules (Yellow/Yellow colored, size '1' hard gelatin capsules with "104" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500 400 mg Capsules (Orange/Orange colored, size '0' hard gelatin capsules with "105" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500 100 mg Capsules (White/White colored, size '3' hard gelatin capsules with "103" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500
Abbreviated New Drug Application
Direct_Rx ---------- Revised: 8/2019 Document Id: 8f9fbc86-2028-b203-e053-2a95a90af299 34391-3 Set id: 8f9fbc86-2027-b203-e053-2a95a90af299 Version: 1 Effective Time: 20190808 Direct_Rx Lestu allt skjalið
GABAPENTIN- GABAPENTIN CAPSULE DIRECT_RX ---------- GABAPENTIN 300 mg Capsules (Yellow/Yellow colored, size '1' hard gelatin capsules with "104" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500 400 mg Capsules (Orange/Orange colored, size '0' hard gelatin capsules with "105" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500 100 mg Capsules (White/White colored, size '3' hard gelatin capsules with "103" printed on body of capsules containing white to off white granular powder) Bottles of 100 & 500 GABAPENTIN gabapentin capsule PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:6 19 19 -6 40 (NDC:49 48 3-6 0 6 ) ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH GABAPENTIN (UNII: 6 CW7F3G59 X) (GABAPENTIN - UNII:6 CW7F3G59 X) GABAPENTIN 30 0 mg INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH STARCH, CO RN (UNII: O8 232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) SHELLAC (UNII: 46 N10 7B71O) LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X) Dire ct_Rx FERRIC O XIDE YELLO W (UNII: EX438 O2MRT) PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3) GELATIN (UNII: 2G8 6 QN327L) PRODUCT CHARACTERISTICS COLOR ye llo w S CORE no sco re S HAP E CAPSULE S IZ E 19 mm FLAVOR IMPRINT CODE 10 4 CONTAINS PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:6 19 19 -6 40 -72 120 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 8 /0 8 /20 19 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE ANDA ANDA0 9 0 0 0 7 0 8 /0 8 /20 19 LABELER - Direct_Rx (079254320) REGISTRANT - Direct_Rx (079254320) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS Dire c t_Rx 0 79 254320 re pa c k(6 19 19 -6 40 ) Revised: 8/2019 Lestu allt skjalið